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

Catalog Number	227305
Medical Device Problem Codes	Product Quality Problem (1506); Device Damaged Prior to Receipt by User (1570); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an in-house engineering evaluation, the vapr 3.5mm hook 1-piece electrode device was found damaged upon receipt.It was initially reported that during an unspecified surgical procedure, the doctor dropped the tripolar device and used the vapr 3.5mm hook 1-piece electrode.Upon opening the electrode, the hook tip was observed missing.The electrode was sent marked with red tape.There were no delays to the surgical procedure.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 the product has not returned to depuy synthes, however photos were provided for evaluation.¿ visual inspection of the returned photos found the active tip missing from the tip.No other anomalies could be observed.An investigation of the photos was performed, which provided with the following results: based on the evidence provided, we can deduce that this observation is consistent with complaints investigated previously, which was originally opened due to out of box failures being reported for the vapr® hook electrode 3.5mm with integrated handpiece.The investigation found that a tip breakage has potentially occurred due to the torque test placing stress on the hook tip, which in turn may result in a breakage occurring during universal blister preparation or after blister visual inspection where the original complaint reported noted that the broken hook tip had pierced the blister packaging.While this condition should have resulted in a reject on this device, it was found during the investigation that reference sample for mitek visual reference standard did not specify inspection of hook tip for breakages.The investigation concluded that inspection criteria were inadequate in the aforementioned documents and corrective/preventative actions were required in the form of updates to documentation and operator training to further clarify.The overall complaint was confirmed as the observed condition of the vapr 3.5mm hook 1-piece electrode -ea would have contributed to the complained device issue.Based on the information currently available, the potential cause is traced to manufacturing.This product issue will be addressed through supplier quality system.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 u2403047, and no non-conformances were identified.The actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.

• 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: 50474054
• Report Number: 1221934-2026-03834
• Device Sequence Number: 10323471
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: (01)10886705009718(10)U2403047(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Distributor
• Type of Report: Initial,Followup
• 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: 227305
• Device Lot Number: U2403047
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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: Male