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

Catalog Number 66800041

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  malfunction  

Event Description

It was reported a water leakage between the hand-piece and the console.There was not a patient involved.

Manufacturer Narrative

The device used in treatment has been returned and evaluated, establishing a relationship between the reported event.A visual inspection found no defects, the functional evaluation found the device did not prime as intended, with the root cause determined as a failed component within the handset.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture, complaint history review found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• 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: 10353350
• MDR Text Key: 201377327
• Report Number: 8043484-2020-02264
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153555
• UDI-Public: 4582111153555
• 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: 03/08/2021

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: 66800041
• Device Lot Number: 50757128
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/31/2020
• Supplement Dates Manufacturer Received: 03/03/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1