MAUDE Adverse Event Report: SMITH & NEPHEW VERSAJET II EXACT; LAVAGE, JET

Catalog Number REF #66800041

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

After opening new versajet ii hydrosurgery system handpiece ref 66800041, lot #50707114, exp date 01/10/2020.Malfunction light came on machine box.Tubing leaking from the connection point with orange part of device.Immediately replaced with a new handpiece, we were able to proceed.

• Brand Name: VERSAJET II EXACT
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW; andover MA 01810
• MDR Report Key: 7534074
• MDR Text Key: 108989934
• Report Number: MW5077378
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Catalogue Number: REF #66800041
• Device Lot Number: 50707114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Weight: 85