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

Catalog Number	225023
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report 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.
Event or Problem Description
It was reported that during a surgical procedure it was observed that when the vapr3 footswitch ea device was removed out of the box it was noted that it was not functioning properly ¿ the ablation pedal was working, however, the coagulation pedal was non-functional.There was no reports of delay in the procedure reported.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: device investigation: the product was returned to depuy synthes for evaluation.Visual inspection of the returned video found that the blue pedal is being activated, however the device is not functioning.Manufacturing investigation results for vapr3 footswitch *ea: during the investigation it was found that no activation occurred when the blue coagulation pedal was pressed.After inspecting the internal components, it was found that the microswitch spring contained within the blue coagulate pedal seems to be incorrectly formed or positioned thereby preventing operation of the coagulation function.It could be seen that the microswitch operating spring was almost flat against the microswitch which prevents the top cover from operating the microswitch.The microswitch itself successfully activated the generator on blue pedal when the switch was pressed.The microswitch is a subcomponent of the foot pedal, supplied to atl uk.An nc was opened to track this failure with the supplier.A deeper investigation will be performed under this action.The overall complaint was confirmed as the observed condition of the vapr3 footswitch *ea would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to manufacturing.This product issue will be addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Video investigation: visual inspection of the returned video found that the blue pedal is being activated, however the device is not functioning.Manufacturing investigation results for vapr3 footswitch *ea: during the investigation it was found that no activation occurred when the blue coagulation pedal was pressed.After inspecting the internal components, it was found that the microswitch spring contained within the blue coagulate pedal seems to be incorrectly formed or positioned thereby preventing operation of the coagulation function.It could be seen that the microswitch operating spring was almost flat against the microswitch which prevents the top cover from operating the microswitch.The microswitch itself successfully activated the generator on blue pedal when the switch was pressed.The microswitch is a subcomponent of the foot pedal 043008, supplied to atl uk.An nc was opened to track this failure with the supplier.A deeper investigation will be performed under this action.

• Brand Name: VAPR3 FOOTSWITCH EA
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23605114
• Report Number: 1221934-2025-04486
• Device Sequence Number: 18604017
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: (01)10886705009114(10)2504001
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2025

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
• Device Lot Number: 2504001
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 02/03/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/11/2025; 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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