MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2014-08-28 for PLASMABLADE 3.0 PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[4908137]
A plasmablade device was being utilized to indirectly cauterize a small vessel, specifically, the vessel was grasped with metal forceps and the plasmablade device was activated on the metal forceps and upon activation the surgeon felt a shock in her hand that was holding the forceps. After the shock the surgeon noted a 1x1mm defect in her glove which exposed her skin and she also complained of a headache. The surgeon completed the case and subsequent to the case reported to the emergency room due to reports of chest pain, blurred vision, and a headache. An ekg was performed in the emergency room and results were negative. Upon a physical exam a scalp burn (where the surgeon had a bobby pin in her hair) was detected but did not require medical treatment. Surgeon complained of fatigue subsequent to the incident for 1-2 days but no additional medical treatment was sought. Both the device and generator are anticipated back for investigation, but are currently held up with the facilities risk management department.
Patient Sequence No: 1, Text Type: D, B5
[12181644]
Product event: eval code method: product scheduled for return but not received by manufacturer for inspection. Eval code results: product scheduled for return but not received by manufacturer for inspection. Eval code conclusion: product scheduled for return but not received by manufacturer for inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20375070]
A plasmablade device was being utilized to indirectly cauterize a small vessel, specifically, the vessel was grasped with metal forceps and the plasmablade device was activated on the metal forceps and upon activation the surgeon felt a shock in her hand that was holding the forceps. After the shock the surgeon noted a 1x1mm defect in her glove which exposed her skin and she also complained of a headache. The surgeon completed the case and subsequent to the case reported to the emergency room due to reports of chest pain, blurred vision, and a headache. An ekg was performed in the emergency room and results were negative. Upon a physical exam a scalp burn (where the surgeon had a bobby pin in her hair) was detected but did not require medical treatment. Surgeon complained of fatigue subsequent to the incident for 1-2 days but no additional medical treatment was sought. Both the device and generator are anticipated back for investigation, but are currently held up with the facilities risk management department.
Patient Sequence No: 1, Text Type: D, B5
[20575442]
(b)(4). Investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: (obtain information from the product line items in gch) please note if there are any discrepancies between the returned device(s), and the device(s) listed within gch. Device name: plasmablade 3. 0s product number: ps210-030s lot number: fl50795858 expiration date: 2017-03-01 quantity returned: one testing performed: visual inspection: (device visual inspection must be filled out for each device returned) device packaging inspection: returned in a cardboard box with styrofoam cushions to fill the negative space the complaint device and tyvek lid is inside a single bio-hazard bag the complaint device name and lot number matches the information in the gch no paperwork was included device visual inspection: the complaint device has been used with dry blood on the hand piece, shaft, and charred blood on the electrode the telescopic shaft when extended, easily dislodged from the hand piece (image1) there are no visible signs related to the description both cut and coag buttons have a tactile feel functional inspection: (if inspection performed, must be filled out for each device tested) functional inspection cannot be performed due to the shaft had dislodged from the hand piece and renders it inoperable. Lhr review: (lot number of returned product or what is populated as the lot number in gch), any deviations, failures, scrap, etc. Pertaining to complaint description) a review of the lhr for lot # fl50795858 revealed: (b)(4). The contact slider detached from the subassembly of the blade/inner shaft causing this subassembly to break off from the device. (b)(4). Investigation conclusion: (complaint confirmed - not confirmed, summary of findings, likely cause of failure, impact of failure to the functionality of the device, recommendations) the reported complaint is not confirmed for reported issue? Plasmablade? 3. 0s shock? Finger. The shaft had dislodged from the hand piece and renders it inoperable to perform any electrical performance testing. As noted in the brief description,? The doctor touched the plasmablade (activated on cut 6) to the metal forceps? It is likely due to miss-use and not following the ifu, as indicted by the doctor touching the active device to the metal forceps which caused the shock that was experienced. The ifu contains warnings for the user that applies specifically as listed below: lbl-00093 rev. C - plasmablade? 3. 0s? Ifu? Instructions for use do not contact metal objects and instruments with the peak plasmablade while power is being applied as unintended tissue damage and electrode tip damage could occur. Activation of the handpiece when not in contact with target tissue may cause capacitive coupling. Do not allow patient contact with grounded metal objects, as such contact may result in patient or user injury. Ensure that only the active tip of the device is in contact with the patient during use. Additionally it was observed that the telescoping shaft detached from the handle. The device was opened up to examine the three spot welds on the contact slider and on the inner shaft and it was determined that they were constructed in their appropriate locations. No corrective action will be taken at this time. The complaint will be tracked and trended in gch. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86568747]
Corrected information: no eval explain code.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00076 |
| MDR Report Key | 4043707 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-08-28 |
| Date of Report | 2014-12-22 |
| Date of Event | 2014-07-31 |
| Date Mfgr Received | 2014-12-22 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2014-08-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAYLEE BOISVERT |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal | 03801 |
| Manufacturer Phone | 6038426234 |
| Manufacturer G1 | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Street | 180 INTERNATIONAL DRIVE |
| Manufacturer City | PORTSMOUTH NH 03801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLASMABLADE 3.0 |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-08-28 |
| Returned To Mfg | 2014-10-20 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | FL50795858 |
| Device Expiration Date | 2017-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC ADVANCED ENERGY, LLC |
| Manufacturer Address | 180 INTERNATIONAL DRIVE PORTSMOUTH NH 03801 US 03801 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-28 |