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

Model Number	66800041
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing to start surgical procedure the versajet hydrosurgery handpiece was set up for use, yet when the team went to prime the tubing for surgeon use it did not initiate this process.Surgical team obtained a new handpiece with no issue.Handpiece saved.Ref # 66800041, lot#(10)51287320, exp: 2/19/2027, manufacturer :smith and nephew.

• Brand Name: VERSAJET
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): SMITH NEPHEW MEDICAL LIMITED; 150 minuteman road; andover MA 01810
• MDR Report Key: 22282743
• Report Number: 22282743
• Device Sequence Number: 18220127
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: (01)00040565124681
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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): 06/11/2025
• Report Date (Section F): 06/11/2025

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: Health Professional
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Device Lot Number: (10)51287320
• 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: 06/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2025
• 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: 06/11/2025