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); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2026
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 sparks/arcs.It was initially reported that before rotator cuff repair surgery, the device's output shorted and did not function.There were no 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.H11: additional narrative: investigation summary a video was provided for evaluation.Visual inspection of the returned video found that the electrode tip was inside of the arthroscopic space without signs of activation.The generator was displaying the error code ¿output shorted¿.No other anomalies were noted.The actual device was returned for evaluation.Visual inspection of the returned device found the device with signs of use.The shaft, tip, cord and handle did not show any signs of damage.No other anomalies could be observed.A functional test was performed by activation of the device, the device was connected to a test generator, also a test footswitch was used, no alert messages were displayed.The ablation function was activated and the error code ¿out put short¿ was displayed.The coagulation function was activated and worked as intended.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, device was received in its original packaging, the active tip was in used condition, procedural residue was found across the distal tip and within suction hole.Ceramic was cracked in several pieces; the shaft was slightly distorted.Procedural residue was visible in suction tube.The device as presented failed electrical testing on hipot active - return and functional testing on footswitch ablation, showing output shorts and sparks.The cracks on the manifold could also be attributed to misuse, as there is evidence of shaft distortion.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 hand switching/one piece lps complaints.Electrodes which exhibit similar failure modes including output shorting, manifold melting, sparking and arcing during a surgical procedure have been further investigated.The customer reported that before the operation, noted the device was output short and does not function.' the device failed both electrical and functional tests.The visual inspection found that the manifold had signs of internal short at the distal tip which was likely damaged by misuse or a shorting event.During ablation activation, sparks were visible which coincided with the output short complaint.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 for the reported condition could be traced to device design.The potential cause for the damaged condition for the ceramic and shaft could be traced to misuse of the device.Relevant actions have been taken to address the issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review a manufacturing record evaluation was performed for the finished device u2506003, 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: 50473476
• Report Number: 1221934-2026-03833
• Device Sequence Number: 13289953
• Product Code: GEI
• UDI-Device Identifier: 10886705009398
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082643
• 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
• 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: U2506003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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
• 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