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

Catalog Number 66800039

Device Problems Difficult to Insert (1316); Failure to Power Up (1476)

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

Event Date 05/23/2020

Event Type  Injury  

Event Description

It was reported that the versajet ii console is not powering on.No procedure was being performed when this was found hence no patient was involved.

Manufacturer Narrative

Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.

Event Description

It was reported that prior to an incision drainage the versajet ii console was tested but was not powering on.Two hand-pieces were tested but neither of them fitted securely, so the device did not work.Since this occurred right before the procedure, the doctor had to use a simpulse irrigator instead for washing out the wound.

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 the events reported, this may include loose connection issues to the electrical outlet.The ifu has been reviewed and contains comprehensive guides on the operation, use and inspection, including steps to be taken in the event of no intermittent electrical power, the associated risk file contains harms related to versajet, however as no harm was alleged within this complaint a review is not required.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: 10084838
• MDR Text Key: 191972625
• Report Number: 8043484-2020-00528
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 04/27/2020
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention