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

Catalog Number 66800044

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

Event Type  malfunction  

Event Description

It was reported that during debridement the serum that comes out the terminal spurts out and cannot enter the terminal again, it splashes.No patient harm reported and treatment was completed with a backup device.

Manufacturer Narrative

H3, h6: the device, used in treatment, has been returned, unfortunately we have not been able to locate the sample for evaluation.Local actions are taking place to prevent re-occurrence.Due to this we have not been able to establish a relationship between the device and the event reported or determine a root cause.Probable causes include blockages, connection issues or a failed component.No batch/lot number has been provided, therefore a review of the device history has not been possible.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary in regards to the failure reported.We will continue to monitor for any adverse trends relating to this product range.Smith + nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.

• 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: 10286628
• MDR Text Key: 199263915
• Report Number: 8043484-2020-02063
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 40565124773
• UDI-Public: 40565124773
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1