MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3 FOOTSWITCH EA; ARTHROSCOPE

Catalog Number	225023
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Use of Device Problem (1670); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a passive surgical procedure on the shoulder while using the vapr3 footswitch ea device the vaporization side of the product stopped working for one to two minutes after the start.Because it was a passive procedure on both sides, while the procedure was being performed on the right shoulder, the user tried to turn off and restart it but it did not work.When the procedure was performed on the other side, the left shoulder, it also worked for the first one to tow minutes but then it stopped working.So the remaining operation was performed in hand mode.There was no delay in the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was 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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.D3, d4, h4; lot/serial number, udi unknown.Expiration date and device manufacturing date are unknown.

• Brand Name: VAPR3 FOOTSWITCH EA
• Common Device Name: ARTHROSCOPE
• 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 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21903073
• Report Number: 1221934-2025-01488
• Device Sequence Number: 8623429
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: (01)10886705009114(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K041135
• 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
• Report Date (Section B): 04/24/2025

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 Catalogue Number: 225023
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown