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

Model Number 66800041

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 11/30/2022

Event Type  No Answer Provided  

Event Description

Versajet ii handpiece making lound noise when pedal is pressed - setting at 8 hooked to saline and unclamped.

• Brand Name: VERSAJET
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH NEPHEW MEDICAL LIMITED; 150 minuteman road; andover MA 01810
• MDR Report Key: 16395951
• MDR Text Key: 309759009
• Report Number: 16395951
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 66800041
• Device Catalogue Number: 66800041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Race: White