MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD VERSAJET; LAVAGE, JET

Model Number	66800042
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Surgical supply inoperable.Replaced with available alternative.

• Brand Name: VERSAJET
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD; 150 minuteman road; andover MA 01810
• MDR Report Key: 22122404
• Report Number: 22122404
• Device Sequence Number: 15242944
• Product Code: FQH
• UDI-Device Identifier: 00040565124698
• UDI-Public: (01)00040565124698
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2025
• Report Date (Section F): 05/15/2025

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
• Operator of Device: Other
• Device Model Number: 66800042
• Device Catalogue Number: 66800042
• Device Lot Number: (10)51278158
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• 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: Unknown
• Date Report Sent to FDA: 05/15/2025