MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,health professional report with the FDA on 2014-12-22 for BIPOLAR SEALER AQM SBS 5.0 23-312-1 manufactured by Medtronic Advanced Energy, Llc.
[5145960]
During the course of the procedure the surgeon went to adjust the device sheath to the "closed" position for sealing when he realized the sheath was not on the shaft. Customer could not recall if the shaft had the sheath when it was initially opened. The customer could not locate the sheath and the packaging had been discarded. A new device was used to successfully complete the case. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[12627562]
(b)(4). Eval, method, results, conclusion: product scheduled for return but not received by manufacturer for inspection. Product event: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38784572]
(b)(4). Investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: aquamantys? Sbs 5. 0 product number: 23-312-1 lot number: unknown expiration date: unknown quantity returned: 1 testing performed: device packaging inspection: aquamantys? Sbs 5. 0 received inside a (b)(6) shipper box with no packaging to fill the negative space and within a single biohazard bag. No original packaging was returned therefore it is not possible to confirm the device information against the information that is listed within (b)(4) nor is it possible to confirm the device that was sent back as the reported complaint device. No paperwork was included. Device visual inspection: device cord has been cut off from the device. Sheath is missing from the device and was not returned. Charring of the electrodes present and the tip housing cracked. Saline within the saline tubing lines. Button has definitive tactile feel. Functional inspection: functional inspection was not performed as the complaint was confirmed via visual inspection. Lhr review: a review of the lhr is not possible as the lot number is listed as unknown within (b)(4). Investigation conclusion: the complaint is confirmed for the? Detached sheath? Issue that was reported in the complaint description. The handpiece incorporates an adjustable sheath at the distal end of the shaft. The sheath can be manually adjusted to two positions. The position in which the product is received "closed" for epidural vein sealing covers the sides of the electrodes leaving only a footprint electrode exposed; the second position "open" exposes the sides of the electrodes for hemostatic sealing and coagulation of soft tissue and bone. Due to there being no sheath on the shaft it was unable to be moved to the closed position. The complaint will be tracked and trended in (b)(4). A likely cause of the failure is the detached sheath. It cannot be determined when the sheath detached, prior to use or if the sheath was inadvertently detached during use as this would impact the proper function and use of the device. Assembly procedure ((b)(4)) at phase2 has two steps in which the sheath is checked. The first step occurs when the device is cleaned and it is confirmed that the sheath is in the closed position. The second step gages the closed position? S tip exposure. It is highly unlikely that a device without a sheath would make it through these two steps unnoticed. Mae also performs incoming inspection of the aqm sbs 5. 0 device. These measures significantly reduce the likelihood of a device without a sheath getting to the field the ifu specially outlines the instructions for use and warnings specifically as listed below: 70-10-1397 rev. F? Aquamantys? Sbs 5. 0? Ifu? Instructions for use: warnings: -while working in the epidural space, always use the device with the sheath in the closed position to avoid unintended thermal damage to adjacent tissue. -while working in the epidural space, adjust the sheath to "closed" to provide the minimum amount of electrode exposure. -when outside the epidural space, adjust the sheath to "open" to provide the maximum amount of electrode exposure. -always confirm the intended sheath position visually and check power and flow settings and adjust to lowest settings required to obtain proper tissue effect after adjusting the sheath. -be aware that all exposed metal on the electrodes is capable of treating tissue. Use caution to avoid inadvertent treatment of tissue and adjacent structures. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[38784573]
During the course of the procedure the surgeon went to adjust the device sheath to the "closed" position for sealing when he realized the sheath was not on the shaft. Customer could not recall if the shaft had the sheath when it was initially opened. The customer could not locate the sheath and the packaging had been discarded. A new device was used to successfully complete the case. No patient impact or injury.
Patient Sequence No: 1, Text Type: D, B5
[103813632]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226420-2014-00133 |
| MDR Report Key | 4349888 |
| Report Source | 05,HEALTH PROFESSIONAL |
| Date Received | 2014-12-22 |
| Date of Report | 2015-04-28 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2015-04-28 |
| Date Added to Maude | 2015-01-07 |
| 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 | BIPOLAR SEALER AQM SBS 5.0 |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-12-22 |
| Returned To Mfg | 2015-01-12 |
| Model Number | 23-312-1 |
| Catalog Number | 23-312-1 |
| Lot Number | UNKNOWN |
| 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 | 2014-12-22 |