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

Model Number	66800041
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Versajet device had been used for approximately 30 minutes without issue; however during priming, surgeons describe the device "was going faster and faster" without changing any settings, and the device made a loud pop noise, and the cables popped off and separated from the device.

• Brand Name: VERSAJET
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): SMITH NEPHEW MEDICAL LIMITED; 150 minuteman road; andover MA 01810
• MDR Report Key: 14287801
• Report Number: 14287801
• Device Sequence Number: 13832739
• Product Code: FQH
• UDI-Device Identifier: 00040565124681
• UDI-Public: (01)00040565124681(17)240104(10)50992957
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/01/2022
• Report Date (Section F): 05/01/2022

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: 50992957
• 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: 05/05/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Hispanic
• Date Report Sent to FDA: 05/01/2022