MAUDE Adverse Event Report: DePuy Mitek LLC US VAPR; Electrosurgical, Cutting & Coagulation & Accessories

Catalog Number	228370
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the operation, electric leakage was noted on the vapr device.Another device was used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.
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 not returned to depuy synthes, however a video was provided for evaluation.Manufacturing investigation results for vapr s90 w/ hand controls: based on the video supplied, we can confirm the video clearly demonstrates sparking occurring in the region of the manifold.This observation is consistent with the failure mode previously investigated.The observed sparking is also consistent with, and provides an explanation for the functional defect reported by the end user.The probable cause of the issue is a shorting event at the distal tip of the device, which can occur as a result of an incomplete adhesive seal.A design change has been identified as the corrective action required to eliminate recurrence of this failure mode.The overall complaint was confirmed as the observed condition of the vapr s90 w/ hand controls would contribute to the complained device issue.Based on the investigation findings, the potential root cause is traced to device design.This product issue was identified during the investigation by the supplier.This product issue will be addressed through the supplier quality system.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 u2602001 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: 50482793
• Report Number: 1221934-2026-03848
• Device Sequence Number: 10112626
• Product Code: GEI
• UDI-Device Identifier: 10886705020935
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial,Followup

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: U2602001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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