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

Catalog Number 66800039

Device Problem Inaccurate Flow Rate (1249)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2020

Event Type  malfunction  

Event Description

It was reported that the unit is spattering at the distal tip of the hand piece.This occurred through multiple hand pieces.It is unknown which procedure was being performed, when the event happened, if there was patient involvement, if there was a delay in the case and if a backup device was available.

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 reported event, may include connection issues, kinks and obstructions, the ifu has been reviewed and contains comprehensive guides on the operation, use and inspection.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: 10117907
• MDR Text Key: 193989533
• Report Number: 8043484-2020-00641
• 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: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1