MAUDE Adverse Event Report: ARTHROCARE CORPORATION WEREWOLF ENT 8-PIN ADAPTER; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	72290136
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an intracapsular tonsillectomy, when using a werewolf wand, the generator displayed the message "wand short circuit" and the werewolf 8-pin adapter seemed to have burnt out in the port.No overheating was noted as a result of the event.The procedure was completed with a change in the surgical procedure, by performing an extracapsular tonsillectomy.There was a surgical delay of less than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate to known inherent device and/or procedural risks that are appropriately documented in our risk files.Smith+nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.Smith+nephew has no reason to suspect that the product failed to meet any specifications at the time of manufacture.Based on our review of all currently available information, we are unable to identify a definitive root cause.However, as the use of our product cannot be excluded as a potential cause or contributory factor to the reported issue, we are conservatively submitting this report in accordance with applicable regulations.If additional information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H6, investigation findings updated.H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation.However, an image evaluation was performed and found two pictures.The first shows an error message in the werewolf ent screen: "wand short circuit please replace wand".The second picture displays the werewolf 8-pin adapter.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, risk management review and instructions for use review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include the wand may have experienced a short or a wire broken inside the wand cable.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H10: h2: additional information on: d1, d4 (catalog number, lot number, expiration date, unique identifier (udi) #) & h4.H11: h2: corrected data on: g4 (pma/510(k)number).
Additional Manufacturer Narrative
H11: h2: corrected data on: d4 (lot number should be left blank).
Event or Problem Description
It was reported that during an intracapsular tonsillectomy, when using a werewolf wand, the generator displayed the message "wand short circuit" and the werewolf 8-pin adapter seemed to have burnt out in the port.No overheating was noted as a result of the event.The procedure was completed with a change in the surgical procedure, by performing an extracapsular tonsillectomy.There was a surgical delay of less than 30 minutes.No further complications were reported.
Additional Manufacturer Narrative
D1/d2a/d2b, d4, d10: udpated.H3, h6: the reported device was received for evaluation.A visual inspection revealed no manufacturing abnormalities.The product was out of the original packaging with no packaging returned.An 8pin adapter was returned with the wand.The 8pin adapter pins have arc/burn damage to them.No issues with the wand.A functional evaluation was performed on the returned device and found no issues with the returned wand.The 8pin adapter cannot be tested due to its damaged pins.An analysis of the customer provided images found two pictures.The first shows an error message in the werewolf ent screen: "wand short circuit please replace wand".The second picture displays the werewolf 8-pin adapter.Insufficient product identification information was provided and thus a manufacturing record review could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A definitive root cause for the reported issue could not be determined.Factors that could have contributed to the event include a damaged receptacle, plugging in a wet wand connector, or exposure of saline to the wand receptacle of the adapter.Based on this investigation, there is no evidence to suggest a design, material or manufacturing issue.Therefore, the need for corrective action is not indicated.

• Brand Name: WEREWOLF ENT 8-PIN ADAPTER
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20077559
• Report Number: 3006524618-2024-00342
• Device Sequence Number: 19589090
• Product Code: GEI
• UDI-Device Identifier: 00885556699942
• UDI-Public: 885556699942
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K202006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 72290136
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 10/01/2024; 01/02/2025; 02/21/2025; 03/07/2025; 03/12/2025
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/08/2024; 01/10/2025; 03/04/2025; 03/07/2025; 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 72290136; 72290144; 72290144, WEREWOLF ENT; EIC8875-01, PROCISE EZ VIEW COBLATOR II
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown