MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL VAPR VUE WIRELESS FOOTSWITCH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	227214
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
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.Device was used for treatment, not diagnosis.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 product was not returned to j&j medtech orthopaedics, however a photo was provided for evaluation.Visual inspection of the returned photo found no observations pertaining to the nature of the reported event or any other anomaly.The overall complaint was not confirmed as the observed condition of the vapr vue wireless footswitch would have not contributed to the complained device issue.Based on the investigation findings, a potential cause cannot be established.Multiple factors are associated with this type of failure, and the complaint device needs to be physically received and evaluated in our service center to determine a potential cause of why the customer experienced the failure.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 j&j medtech orthopaedics 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.
Event or Problem Description
It was reported that during an unspecified surgical procedure the vapr vue wireless footswitch device when pressing down on the ablate button (yellow pedal) it would not work or it would work for two seconds and then short out.Another pedal was used to complete the procedure.The exact date of this event was unknown but was noted to have occurred in 2025.There was no delay in the procedure reported.There were no adverse patient consequences reported.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 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: d9, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: investigation summary: the complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: device being sent to lth due to rust/corrosion on the baseplate and illegible lot number label.Functional : electrical/electronic component failure and visual : corrosion/rusting/pitting.Per service reports, this complaint was confirmed.Based on service manual operational and diagnostic, the device was found to be non-repairable, and it was placed into long term hold.Based on the investigation findings, the potential root cause is traced to faulty parts.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics 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.

• Brand Name: VAPR VUE WIRELESS FOOTSWITCH
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 22094717
• Report Number: 1221934-2025-01908
• Device Sequence Number: 6935580
• Product Code: GEI
• UDI-Device Identifier: 10886705009657
• UDI-Public: (01)10886705009657(10)INCOMPLETE
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K100638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2025

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: 227214
• Device Lot Number: L32498400010107-TXA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 06/16/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/13/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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