MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	228504
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Melted (1385); Device Contaminated During Manufacture or Shipping (2969); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
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: e1: the reporter¿s complete facility address was not provided.Investigation summary the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found signs of usage on the overall device surface.The shaft, tip, cord and handle did not show any signs of damage.No other anomalies were noted.A functional test was performed by activation of the device; the device was connected to a test generator, and the electrode was immediately recognized.The coagulate and ablate function were tested for hand controls, the error code ¿out put short¿ was displayed when the ablate test was performed and the coagulation test did not work as intended.The device will be sent to the manufacturer for further testing.The supplier performed an evaluation with the following results: device was received in its original packaging.The tip components were in used condition, with some residue around the manifold and the active tip charred.The handle, cable and plug assembly were used, and there was observed procedural residue visible in suction tube.There were no ncrs or deviations raised during the manufacturing process of this device.The customer reported that ¿during the surgery, button fails and device does not operate when depressed.¿ the electrode passed electrical tests, however failed activation using the handswitch coagulation (blue button) function with no button response.Further internal inspection showed evidence of saline ingress (on the pcb switch coag & mode, cut return clip, rubber button).Positive pressure testing of the suction pathway via the enteral adaptor, with the distal tip occluded, identified leakage at the proximal end of the return tube.This was further confirmed when the distal tip was submerged in water with the suction tube blocked, with leakage again observed at the proximal end of the return tube.The coagulation button was functioning correctly following cleaning of a thin layer of residue from the contacts.Further investigation revealed that there was a poor glue seal at the device tip to the suction tube.This leak is causing saline to escape out of the suction tube to then run down the inside of the return tube, then inside the handle causing the saline to get into the switch consequently shorting it.Looking at process adhesive bonding - tip/tube assembly, the suction tube to ceramic tip step in the assembly process has not been performed correctly.This complaint can be classified as a manufacturing fault.The overall complaint was confirmed as the observed condition of vapr p50 w/ hand controls would have contributed to the complained issue.Based on the investigation findings, the potential cause for the observed condition is traced to manufacturing.The product issue has been 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.
Event or Problem Description
It was reported that during an arthroscopy hip gluteal muscle contracture surgical procedure, when using the vapr p50 w/ hand controls device, it was observed that the buttons failed, and the device did not operate when the buttons were depressed.It was reported that another device was used to complete the procedure.During in-house engineering evaluation it was determined that the coagulation test did not work as intended, and the tip components were in used condition, with some residue around the manifold and the active tip was charred.There were no adverse consequences related to the patient.No additional information could be provided.

• Brand Name: VAPR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 25363867
• Report Number: 1221934-2026-02364
• Device Sequence Number: 9994519
• Product Code: GEI
• UDI-Device Identifier: 10886705020942
• UDI-Public: (01)10886705020942(10)U2409004(17)270924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K120095
• 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

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: 228504
• Device Lot Number: U2409004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown