MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227305
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an anterior cruciate ligament repair surgery, it was observed that the vapr 3.5mm hook 1-piece electrode device could not cut and could not coagulate.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H.11.Additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11.Additional narrative: the products were returned to depuy synthes for evaluation.Visual inspection of the returned device found it was not returned in its original package.The tip, handle, shaft and plug did not show any signs of damage.A functional test was performed by activation of the device, the device was connected to a test generator, also a test footswitch was used, the default values were displayed correctly (vapr vue, ablate power 120 and coagulate power 90), no alert messages were displayed.The ablation function was activated using the foot pedal several times in its maximum power for one minute each test, and it sounded as if it was working however no visual activation signs were observed.The coagulation function was activated using the foot pedal several times in its maximum power for one minute each test, and it worked as intended.The device will be send to the manufacturer for further testing.A visual inspection of the device was performed by the manufacturer; as a result, device was not received in its original packaging, the tip had light usage seen through the discoloration and rounding of the tip of the hook, and discoloration of the return electrode, there were light scratch marks across the ceramic.The device passed all functional and electrical testing.During the investigation, it was found that the device performed as expected, with no observations being noted.The complaint cannot be substantiated.The overall complaint was no confirmed as the observed condition of vapr 3.5mm hook 1-piece electrode-ea would have not contributed to the complained issue.Based on the investigation findings, the potential cause for the observed condition is traced to the procedural variables, such handling of the device or normal product interaction during procedure.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: correction: h4: the device manufacture date was reported as 2/9/2023 in the initial report.Please note that the date of manufacture has been updated to 3/2/2023.

• Brand Name: VAPR 3.5MM HOOK 1-PIECE ELECTRODE -EA
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 23052538
• Report Number: 1221934-2025-03525
• Device Sequence Number: 9741835
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: (01)10886705009718(10)U2302063(17)260131
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 227305
• Device Lot Number: U2302063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 09/17/2025; 09/23/2025; 11/19/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 09/18/2025; 09/24/2025; 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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
• Patient Sex: Unknown