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

Catalog Number	227214
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
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: a photo was provided for evaluation.¿ visual inspection of the returned photo found no observations pertaining to the nature of the reported event or any other anomaly.The complaint device was received at the service center and evaluated.During the service evaluation the following defects were identified: broken (2+ pieces) : chipped/shaved/delaminated and functional : pairing failure.Per service reports, this complaint was confirmed.Based on the investigation findings, the potential root cause is traced to improper maintenance.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.
Event or Problem Description
It was reported that during in-house engineering evaluation, it was determined that the vapr vue wireless footswitch device was chipped/shaved/delaminated.It was initially reported that preoperatively to an unknown procedure, it was observed that the wireless foot pedal was not working properly.It was reported that there were no delays in the surgical procedure.The procedure was completed successfully.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown.However, it was reported that the event occurred in 2026.All available information has been disclosed.

• 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 ; +1(908)386-3534
• MDR Report Key: 50721121
• Report Number: 1221934-2026-04077
• Device Sequence Number: 10159536
• Product Code: GEI
• UDI-Device Identifier: 10886705009657
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

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: 227214
• Device Lot Number: L32498400010152-TXA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2018
• 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