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

Catalog Number 66800041

Device Problems Defective Device (2588); Priming Problem (4040)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during the preparation of debridement utilizing a versajet, the hand-piece didn't complete its self-priming.The problem was solved by exchanging the hand-piece.There was no delay nor patient involved.The device will be returned for investigation.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device used in treatment has been returned and evaluated, no visual or functional faults where found.No relationship was established between the reported event or determine a root cause.Probable root cause include kinks and blockages, the ifu offers further guidance.No batch/lot number has been provided, therefore a review of the device history has not been possible.The complaint history file contains further instances of the reported event.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• 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 east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10077033
• MDR Text Key: 191662199
• Report Number: 8043484-2020-00493
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800041
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1