MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET PLUS ASSY, 45 DEGREE X 14MM; LAVAGE, JET

Catalog Number 66800044

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Information (3190)

Event Date 10/15/2018

Event Type  malfunction  

Event Description

It was reported that doctor was using the versajet handle for a wound debridement for about 30 minutes in the case.He stopped using the handle, to work on the wound for a few minutes.When he went to restart the handle, there was not pressure or saline coming out.The braided tubing broke by the key at point of insertion.No delay reported.He finished using a scalpel.

Manufacturer Narrative

As of today, device return has been requested for this complaint but has not yet been made available to the designated complaint unit for a full evaluation.Without return of the actual device we cannot further investigate or confirm the details supplied in this complaint and try to determine a root cause.If the device is returned in the future then this complaint may be reopened.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.

• Brand Name: VERSAJET PLUS ASSY, 45 DEGREE X 14MM
• Type of Device: LAVAGE, JET
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 8087635
• MDR Text Key: 127856382
• Report Number: 8043484-2018-00400
• Device Sequence Number: 1
• Product Code: FQH
• 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,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800044
• Device Lot Number: 50747980
• Date Manufacturer Received: 11/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1