MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR S90 W/ HAND CONTROLS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	228370
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2025
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.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, and no conclusion can be drawn at this time.
Event or Problem Description
It was reported that during a rotator cuff repair, the vapr s90 w/ hand controls device generated sparks.It was noted that the failure could be due to electric leakage.It was reported that the device was not used in patient.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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the actual device was returned for evaluation.However, since the investigation is still on-going, the assignable root cause could not be determined at this time.Once investigation has been completed, a follow-up report will be submitted 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 report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the device comes in used condition.The device was connected to a test generator and the device failed the ablation and coagulation functions.The device will be sent to the manufacturer for further analisys.Manufacturing investigation results for vapr s90 w/ hand controls: the device was received in a bag only, not in original packaging.Tip components are in good condition, lightly used, saline residue on active tip and manifold.Handle assembly is in good condition.Cable and plug are in good condition.Saline residue in suction tube.Electrical checks: the device failed the active continuity parameter.Functional checks: the device failed the hand activation and footswitch activation on ablate and coagulation modes.As a result of the failed checks as stated above, further investigation was undertaken.The device handle was opened to investigate the electrical wiring.The active wire insulation was stripped.The continuity failed with an "overload" value.The active wire was further stripped and the active continuity passed.Continuity failed with an "overload" value; meaning a failure in connection between the initial red active wire to the yellow active wire and is a manufacturing fault.Due to the break in continuity between the two points between the active wire from the tip, and the connecting red wire to the harness.The break in connection was at the solder joint, inside the glue pocket in the lower handle.When the handle was dismantled, it was observed that there was a small gap in the solder of the two wires.This device is subjected to 100% batch sample power circuit continuity testing and 100% batch sample functional testing.This device will have been tested before being released as finished goods and would have been scrapped if it had failed tests on the line.It was noted that there were observations of light use on the electrode, and a potential root cause (although unlikely) for the reported fault of 'sparking/arc" could have been down to flexion of the handle during the procedure.If the handle and shaft are put through flexion, this could potentially bend the glue pocket out of position and intermittently touch the wires together, causing the spark, but we are unable to confirm this through our investigations.The root cause of the fault observed through further investigation is inadequate soldering of the electrical wiring due to process not being followed.The overall complaint was not confirmed as the observed condition of the vapr s90 w/ hand controls would have not contributed to the complained device issue.¿ based on the investigation findings, the potential cause for inadequate soldering of the electrical wiring 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.A manufacturing record evaluation was performed for the finished device u2410004 number, and no non-conformances were identified.

• Brand Name: VAPR S90 W/ HAND CONTROLS
• 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 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 23066980
• Report Number: 1221934-2025-03549
• Device Sequence Number: 13272848
• Product Code: GEI
• UDI-Device Identifier: 10886705020935
• UDI-Public: (01)10886705020935(10)U2410004(17)271022
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K122425
• 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

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: 228370
• Device Lot Number: U2410004
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/02/2025; 12/09/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/06/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2024
• 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
• Patient Sex: Unknown