MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; LAVAGE, JET

Catalog Number 66800039

Device Problem Leak/Splash (1354)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2020

Event Type  malfunction  

Event Description

It was reported that the unit was found to be dripping at key insertion.This occurred through multiple hand pieces.A loaner unit was supplied for the meantime and the products wasted were replaced.

Manufacturer Narrative

The device, which was used in a procedure, was not returned for evaluation.A relationship between the device and the reported incident could not be confirmed, therefore the root cause is undetermined at this time, if the product is returned in the future the complaint can be reopened and evaluated.However factors that are known to contribute to this kind of issue, may include deposits and/or debris buildup in the pump interface.The ifu has been reviewed and contains comprehensive guides on the operation, use and inspection, including steps to be taken in the event of cleaning the pump interface, a plan has been implemented to change the plastic insert to reduce re-occurrences of this issue.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.Our quality department will continue to monitor for trends.

• Brand Name: VERSAJET II CONSOLE
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10140656
• MDR Text Key: 194777050
• Report Number: 8043484-2020-00684
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153524
• UDI-Public: 4582111153524
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800039
• Date Manufacturer Received: 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1