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

Catalog Number 66800039

Device Problems Failure to Prime (1492); Noise, Audible (3273)

Patient Problem Injury (2348)

Event Date 05/06/2020

Event Type  Injury  

Event Description

It was reported that the 1l bag of ns ran dry during the procedure.The surgeon hung a second bag but the hand-piece wouldn't flush, there was also a sound with the pedal, another bag was tried but didn't work either.The surgeon chose to complete the procedure debriding without the versajet.No further complications were reported.

Manufacturer Narrative

The device used in treatment was not returned for evaluation, therefore we could not establish a relationship between the reported event or determine a root cause on this occasion, probable causes include, kinks leaks and blockages, the instructions for use has been reviewed and offer further guidance with regards to priming.The associated risk files contain the reported failure/harm or event.However, as no harm has been alleged then additional review is not required.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances; however, this investigation is now complete with no further action deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.

• 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: 10164038
• MDR Text Key: 195445223
• Report Number: 8043484-2020-00789
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153524
• UDI-Public: 4582111153524
• Combination Product (y/n): N
• PMA/PMN Number: K143115
• 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: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800039
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention