MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-28 for PLASMABLADE PS300-002 4PK TNA manufactured by Medtronic Advanced Energy, Llc.
[4907571]
During utilization of the plasma blade tna device, the adenoid electrode wire sparked and it was noticed that after the spark, the electrode wire was fractured. It is hard to determine if the device was in direct contact with tissue when spark occured. Oxygen setting below 20%. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
[12181225]
Product event: (b)(4). Method, results, conclusion: device returned and analysis underway; analysis results pending. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35332131]
Product event # (b)(4). Testing performed: device packaging inspection: received in medtronic corrugated cardboard box, with plastic air cushions to fill the negative space. Received in single biohazard bag. No original packaging included, therefore device information cannot be confirmed against the product event page within gch, nor is it possible to confirm that the device that was sent back as the reported complaint device. No additional paperwork included device visual inspection: hand-piece, adenoid tip, and suction coag returned. All device appear used as indicated by blood splatter and charring on electrodes and suction connector buttons have a definitive tactile feel. All components appear intact and in place. Adenoid tip has a fracture in wire. See pictures below. Functional inspection: tips exhibited the following tensile strength when pulled from the handpiece using the shimpo force gage. Force to attach (2. 0 to 12. 0 lbs required per product specification) adenoid tip : average = 17. 2 lbs stdev = 2. 6 lbs suction coag: average = 13. 3 lbs stdev = 2. 0 lbs force to remove (2. 0 to 12. 0 lbs required per product specification) adenoid tip : average = 16. 5 lbs stdev = 1. 0 lbs suction coag: average = 12. 1 lbs stdev = 0. 7 lbs (see chart on attached investigation form for more specific details on force required to attach and remove device tip) lhr review: lhr 0007080354 was reviewed and no similar failures were noted in the record. Investigation conclusion: the complaints have been confirmed. The adenoid tip wire is fractured on the returned device. This complaint has been seen in the past and been addressed through a situation analysis ((b)(4)). A capa ((b)(4)) is currently open as well to address this issue. The adenoid tip is difficult to attach to the handle ten trials of insertion and removal of the adenoid tip were evaluated and averaged 17. 2 lbs. Force for insertion and 16. 5 lbs. Force for removal. This fails the requirement for the adenoid tip: (reference 31-10-1370 rev b)? ? Force to insert and remove from the suction shaft must be between 2. 0 lbs. And 12. 0 lbs.? A plausible cause is that the basket ribs of the adenoid connector are deformed enough to create a smaller inside diameter hence making the insertion a much tighter fit than acceptable. This complaint will be monitored in gch for future instances and an investigation will be elevated should this complaint failure become more prominent. The suction coag is difficult to attach to the handle ten trials of insertion and removal of the suction coag were evaluated and averaged 13. 3 lbs. Force for insertion and 12. 1 lbs. Force for removal. This fails the requirement for the adenoid tip: (reference 31-10-1370 rev b)? ? Force to insert and remove from the suction shaft must be between 2. 0 lbs. And 12. 0 lbs.? A plausible cause is that the basket ribs of the connector are deformed enough to create a smaller inside diameter hence making the insertion a much tighter fit than acceptable. This complaint will be monitored in gch for future instances and an investigation will be elevated should this complaint failure become more prominent. Reference documents: 31-10-1370 rev b product and specification plan-plasmablade tna product family 42-10-1020 rev c complaint investigation work instructions test equipment: eqp #: shimpo force guage eqp #: tna pull force fixture. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[35332132]
During utilization of the plasmablade tna device the adenoid electrode wire sparked and it was noticed that after the spark the electrode wire was fractured. It is hard to determine if the device was in direct contact with tissue when spark occured. Oxygen setting below 20%. No patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226420-2014-00074 |
| MDR Report Key | 4043640 |
| Report Source | 06,07 |
| Date Received | 2014-08-28 |
| Date of Report | 2014-09-30 |
| Date of Event | 2014-07-30 |
| Date Mfgr Received | 2014-09-30 |
| Date Added to Maude | 2014-09-12 |
| 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 PS300-002 4PK TNA |
| Generic Name | ELECTROSURGICAL DEVICE |
| Product Code | DWG |
| Date Received | 2014-08-28 |
| Returned To Mfg | 2014-08-04 |
| Model Number | PS300-002 |
| Catalog Number | PS300-002 |
| Lot Number | 0007080354 |
| Device Expiration Date | 2017-03-26 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 |