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

Model Number	227305
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Upon opening device, the physician noticed there should be a hook on the end of the device but no hook was present.Physician opened a new device and that was used for the case.

• Brand Name: VAPR
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): DEPUY MITEK, LLC; 325 paramount dr; rayham MA 02767
• MDR Report Key: 21196572
• Report Number: 21196572
• Device Sequence Number: 7475732
• Product Code: GEI
• UDI-Device Identifier: 10886705009718
• UDI-Public: (01)10886705009718
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2025
• Report Date (Section F): 01/15/2025

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
• Device Model Number: 227305
• Device Catalogue Number: 227305
• Device Lot Number: U2407001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 01/21/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/21/2025
• 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: Prefer Not To Disclose
• Date Report Sent to FDA: 01/15/2025