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

Catalog Number	228504
Medical Device Problem Codes	Infusion or Flow Problem (2964); Device Contaminated During Manufacture or Shipping (2969); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2026
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: 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 suction tube was cut off and the black coating on the shaft was broken.The tip and shaft had scratches and were deformed.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.Test revealed that only the coagulation function could be activated as intended.Intermittence was identified while pressing the ablation button.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 tissue debris in the active tip, saline crystallization on the tip and eschar build up on manifold.The handle, cable and plug assembly were used.In addition, there was observed procedural residue visible in suction tube and heat-shrink damaged on the distal end.There were no ncrs or deviations raised during the manufacturing process of this device.The customer stated that ¿alert & could not fire.This event involved 3 devices.¿ testing verified the reported issue, with the electrode output short-circuiting during hand-switch and foot-switch activation in ablate mode.The device failed flow rate test before and post activation as well.The electrode additionally failed the dielectric withstand (hipot active - return) test.Further investigation was conducted.The electrode handle was taken apart which revealed debris inside, at the end of the outer shaft.A water pressure test was performed which revealed a lack of glue at the tip sealing off the suction tube from the outer shaft.This would have caused saline to leak inside the outer shaft and into the handle.The reported defect has been confirmed and can be attributed to a manufacturing fault - insufficient adhesive applied at process tip assembly adhesive application.This is a known failure mode caused by an insufficient application adhesive (operator applies insufficient adhesive) resulting in an electrical failure.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 a meniscal repair surgical procedure, while using the vapr p50 w/ hand controls device, it was observed that an abnormality alarm was found.During in-house engineering evaluation it was determined that tissue debris was in the active tip, saline crystallization on the tip and eschar build up on manifold.It was further determined that there was suction failure.Another device was used to complete the surgery.There were no adverse consequences 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: 25379840
• Report Number: 1221934-2026-02386
• Device Sequence Number: 21198019
• Product Code: GEI
• UDI-Device Identifier: 10886705020942
• UDI-Public: (01)10886705020942(10)U2506006(17)280629
• 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): N
• 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: U2506006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2025
• 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