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	08/28/2025
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: 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 rotator cuff repair procedure, the vapr s90 w/ hand controls device generated sparks and could be due to electric leakage.(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 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 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.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.H10 additional narrative: investigation summary: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the tip showed signs of activation, the tubbing had foreign matter residue.The tip, handle, shaft and plug did not show any signs of damage.A functional test was performed and the device activated as intended for both modes with footswitch.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 the device was received in its original packaging, the tip was in used condition, residue was visible on the active tip and within the suction hole.The suction tube had residue within.Upon inspection of the pcb appeared cloudy around the coag and mode buttons.There were also saline crystals surrounding the pcb signifying the introduction of saline into the area.There was rusting on the return clip with some copper oxidation evident.No leakage was visible from the test.Further investigation will be necessary to find the origin of the saline.The device passed all electrical tests.It failed to coagulate using the handswitch and failed both pre and post activation flow rates tests.The ablate activation was as expected with no sparks generated.The complaint of ¿sparks & electrical leakage¿ cannot be substantiated as the results were not able to be replicated.The overall complaint was no confirmed as the observed condition of vapr s90 w/ hand controls 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.As per the instructions for use, do not allow the electrode to become covered in tissue debris.If this occurs, use a new electrode.Additionally, electrodes will wear from normal use, depending on factors such as length of use, high tissue removal rate, prolonged use against bony surfaces, prolonged use in saline, high power settings, and use with minimal suction or fluid management.Periodically assess electrode tip for wear and proper operation.Replace the electrode if excessive wear is noted.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.Device history lot: a manufacturing record evaluation was performed for the finished device 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: 23049915
• Report Number: 1221934-2025-03506
• Device Sequence Number: 13155021
• Product Code: GEI
• UDI-Device Identifier: 10886705020935
• UDI-Public: (01)10886705020935(10)U2309009(17)260831
• 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
• 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: 08/31/2026
• Device Catalogue Number: 228370
• Device Lot Number: U2309009
• 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; 12/08/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/02/2025; 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown