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

Catalog Number	228370
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the vapr device had a melted manifold and sparks/arcs.It was noted in the service order that the device had an output short during acl (ant.Cruciate ligament) repair surgery.Another device was used to complete the surgery.There were no adverse consequences to the patient.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the device with signs of use.The active tip had the manifold charred at the distal end.The shaft, tip, power cord and handle did not show any signs of damage.The device will be sent to the manufacturer for further testing.A visual inspection of the device was performed by the manufacturer; as a result, device was received in its original packaging.The active tip was used, tissue debris visible in suction tube, cracked charred manifold.Procedural residue visible in suction tube.The device failed the electrical testing (hipot active- return) and the functional testing (visible spark and output short for the ablate function).There was visible damage to the upper manifold and activation tests confirmed that arcs (sparks) were visible during ablate function tests, as well as during the function test for hipot.The customer complaint can be substantiated.Based on the evidence of the damaged section of the upper manifold seen for the returned electrode, the likely cause of this failure is shorting at distal tip.The failure mode seen is consistent with previous s90 hanswitching/one piece lps complaints.Electrodes which exhibit similar failure modes including output shorting, manifold melting, sparking and arcing during a surgical procedure and have been further investigated through previous capa.The overall complaint was confirmed as the observed condition of the vapr s90 4.0mm w/integr hdp -ea would have contributed to the complained device issue.Based on the information currently available, the potential cause is traced to design.This product issue will be addressed through supplier 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 u2502001, and no non-conformances were identified.

• 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: 25432129
• Report Number: 1221934-2026-02439
• Device Sequence Number: 10095674
• Product Code: GEI
• UDI-Device Identifier: 10886705020935
• UDI-Public: (01)10886705020935(10)U2502001(17)280210
• 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,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: 228370
• Device Lot Number: U2502001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown