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

Catalog Number 66800041

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2018

Event Type  malfunction  

Event Description

It was reported that during debridement utilizing versajet hand-piece, the saline jet stopped.The surgery was completed with surgical knives.There was no patient harm.

Manufacturer Narrative

We have now completed our investigation into the returned versajet hand piece.A visual inspection was carried out and no problems were found.Functional testing was carried out and this confirmed the reported issue.The device was found to leak water and the location of the leak was at the weld where the jet tube meets the filter assembly.Unfortunately on this occasion we were unable to determine the root cause of this failure and a device history review was not possible as no lot number was provided.

• Brand Name: VERSAJET EXACT 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD; 101 hessle road; hull, HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull, HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7819565
• MDR Text Key: 118395054
• Report Number: 8043484-2018-00255
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1