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

Catalog Number	225024
Medical Device Problem Codes	Computer Software Problem (1112); Mechanical Problem (1384); Blocked Connection (2888)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
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 complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: error code: 200 per service report, this complaint was confirmed.The circuit board were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.Based on the investigation findings, the potential root cause is traced to faulty parts.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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 serial number, and no non-conformance was identified.
Event or Problem Description
It was reported that during a demonstration of the vapr vue generator device it was observed that the device contact connection was poor, which led to an unprovoked restart.During in-house engineering evaluation it was determined that the device displayed an error code: 200 (internal hardware failure).This event did not occur during a surgical procedure.There were no adverse consequences related to the patient.All available information has been disclosed.No additional information could be provided.

• Brand Name: VAPR VUE
• 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: 25545760
• Report Number: 1221934-2026-02657
• Device Sequence Number: 16138897
• Product Code: GEI
• UDI-Device Identifier: 10886705009121
• UDI-Public: (01)10886705009121
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K041135
• 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: 225024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown