MAUDE Adverse Event Report: DePuy Mitek LLC US VAPR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	225370
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Melted (1385); Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during in-house engineering evaluation, it was determined that the vapr s90 4.0mm w/integr hdp device had a melted manifold, sparks/arcs and foreign substance/debris/cleaning/sterilization.It was initially reported that during a shoulder arthroscopy surgery, the device's output shorted.It was not reported if there were any delays to the surgical procedure.It was reported that a spare device was used to complete the surgery.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.Investigation summary: a photo was provided for evaluation.Visual inspection of the returned photo found that the generator is displaying "output shorted" message.No other anomalies were noted.The actual device was returned for evaluation.Visual inspection of the returned device found that the device comes in used condition.The active tip shows activation marks.The device was connected to a test generator.Output shorted error was displayed.Manufacturing investigation results for vapr s90 4.0mm w/integr hdp -ea: device received in original packaging: yes.Tip components condition: used, burnt manifold, cracked ceramic, procedural residue across distal tip and within suction hole.Handle assembly condition: used, no misuse, light residue staining on handle.Cable and plug assembly condition: used, procedural residue visible in suction tube.Electrical checks: the device failed the hipot active- return parameter.Functional checks: the device failed the footswitch activation on the ablate function, sparks and output short error.The visual inspection found that the plastic manifold is melted at the distal tip which was likely damaged by misuse or a ¿shorting' event.The specific root cause cannot be determined.During functional testing, during ablation activation, sparks were visible.No plasma was visible during activation.The complaint of 'output short' can be substantiated.Based on the evidence of the damaged section of the 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 handswitching/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.To eliminate recurrence of this failure mode, a design change is required.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 investigation findings, a potential cause is traced to device design.The issue is being addressed through a capa.The assignable root cause was due to design.Depuy synthes will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.Device history review: a manufacturing record evaluation was performed for the finished device u2506009 number, 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 ; +1(908)386-3534
• MDR Report Key: 50473245
• Report Number: 1221934-2026-03831
• Device Sequence Number: 21360391
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• UDI-Public: (01)10886705009398(10)U2506009(17)280624
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 225370
• Device Lot Number: U2506009
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 08/27/2026
• 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): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown