MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET EXACT ASSY, 15 DEGREE X 14MM; LAVAGE, JET

Catalog Number 66800040

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/30/2020

Event Type  malfunction  

Event Description

It was reported that the membrane of the chip was already broken and it was leaking water.No harm or injury reported.

Manufacturer Narrative

The device, was not used in a procedure was not returned for evaluation with all additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found other related failures.Probable cause may be a component failure.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: VERSAJET EXACT ASSY, 15 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: 10446278
• MDR Text Key: 204158862
• Report Number: 8043484-2020-02601
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800040
• Device Lot Number: 50820625
• Initial Date Manufacturer Received: 07/31/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 03/24/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1