MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-12-15 for PLASMABLADE 3.0 WIDE SPATULA PS210-030S manufactured by Medtronic Advanced Energy, Llc.
[5249847]
Approximately 1 hour into a breast reduction case the surgeon noticed a piece of clear plastic (the heat shrink) had detached from the plasma blade tip. Upon detachment the plastic affixed to the electrode and did not make contact with the patient. The doctor removed the plastic from the electrode with a pair of tweezers. The surgeon continued the case with the same plasmablade. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
[12705599]
(b)(4). Evaluation (method): device returned to manufacturer and pending analysis. Evaluation (result): device returned to manufacturer and pending analysis. Evaluation (conclusion): device returned to manufacturer and pending analysis. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[37881015]
(b)(4) investigation plan: visual inspection functional inspection (if applicable) lhr review complaint device details: device name: plasmablade 3. 0s product number: ps210-030s lot number: r1a0762385 expiration date: 2017-03-18 quantity returned: 1 testing performed: device packaging inspection: returned in a (b)(6) box with no packaging to fill the negative space device is in a single bio-hazard bag and no original packaging is included device cannot be confirmed with the information listed in gch nor as the reported complaint device hand written note with the rga number was included small plastic container marked with lot number r1a0762385 with the detached plastic shrink wrap inside was returned. Figure 2. Device visual inspection: device appears to be used with charred blood on electrode, dried blood on hand piece, cord, and inside clear suction tubing. Tubing and cord are taped together. All components appear to be intact with exception to the missing heat shrink. The missing heat shrink is the visual sign related to the description. Figure 1. Both cut and coag buttons have a tactile feel. Functional inspection: -the plasmablade 3. 0s was connected to the complaint lab pulsar ii generator and the expected e5 error code, end of life, was displayed indicating that the device had been successfully activated by a pulsar generator prior to complaint investigation. -the device was tested for functionality, per 42-10-1020 rev. C; the device was activated in grounded saline in the collapsed position, at cut setting? 2 and coag setting-1, settings used for testing during manufacturing, with acceptable results. -the device is acceptable if the? Glow? Around the edge of the blade is observed and an audible high pitch noise is heard coming from the generator when both buttons cut and coag are actuated? , which was observed during functional inspection of the complaint device. Lhr review: a review of the lhr # 208148430 for lot # r1a0762385 revealed that there were no problems during manufacturing that can be associated with the reported complaint. Investigation conclusion: the complaint is confirmed for the? Detached? Clear shrink wrap? Issue that was reported in the complaint description. Visual inspection confirmed the heat shrink was detached from the electrode as well as there was an accumulation of tissue build-up in the suction opening of the finger grip causing the device to become clogged. The finger grip incorporates a suction lumen for the evacuation of smoke and fluids. The likely cause of the failure is user misuse by allowing the suction opening to become clogged with an excessive build-up of tissue resulting in the overheating and melting of the heat shrink. The rf energy is affected by the clog or gunk build-up and causes a change to the electrical path causing the energy to be directed to the tissue attached to the device (in this case near the heat shrink) rather than to the patient. When the energy path is directed to the tissue on the heat shrink, the component experiences high temperature and over time, it is possible for the heat shrink to degrade. The complaint will be tracked and trended in gch. Ifu? Precautions: -during surgery: note: eschar buildup on the tip can be removed manually with gloved fingers or gauze pads, or by inserting the tip into the slot at the front of the holster and drawing the device backwards through the slot. Inspect the device for any signs of damage after cleaning. -activation of the hand piece simultaneously while aspirating fluid may alter the path of electrical energy away from target tissue.
Patient Sequence No: 1, Text Type: N, H10
[37881016]
Approximately 1 hour into a breast reduction case the surgeon noticed a piece of clear plastic (the heat shrink) had detached from the plasma blade tip. Upon detachment the plastic affixed to the electrode and did not make contact with the patient. The doctor removed the plastic from the electrode with a pair of tweezers. The surgeon continued the case with the same plasmablade. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00121 |
| MDR Report Key | 4328459 |
| Report Source | 06,07 |
| Date Received | 2014-12-15 |
| Date of Report | 2015-04-08 |
| Date of Event | 2014-11-17 |
| Date Mfgr Received | 2015-04-08 |
| Device Manufacturer Date | 2014-03-19 |
| Date Added to Maude | 2014-12-29 |
| 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 | 0 |
| Event Location | 0 |
| 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 WIDE SPATULA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-12-15 |
| Returned To Mfg | 2014-11-24 |
| Model Number | PS210-030S |
| Catalog Number | PS210-030S |
| Lot Number | R1A0762385 |
| Device Expiration Date | 2017-03-18 |
| 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 | 2014-12-15 |