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

Model Number	66800045
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Versajet machine fault light error.

• Brand Name: VERSAJET
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): SMITH NEPHEW MEDICAL LIMITED; 150 minuteman road; andover; andover MA 01810
• MDR Report Key: 25315960
• Report Number: 25315960
• Device Sequence Number: 9893743
• Product Code: FQH
• UDI-Device Identifier: 00040565124780
• UDI-Public: (01)00040565124780
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/21/2026
• Report Date (Section F): 05/21/2026

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
• Device Model Number: 66800045
• Device Catalogue Number: 66800045
• Device Lot Number: 51329035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Date Report Sent to FDA: 05/21/2026