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

Catalog Number 66800041

Device Problem Failure to Prime (1492)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2020

Event Type  malfunction  

Event Description

It was reported that during set up the device failed to prime so the water only got to the middle of the hose and did not reach the head of the handpiece.

Manufacturer Narrative

The device intended for use in treatment was returned for evaluation and we have established a relationship between the device and the reported event.A visual inspection was performed and showed the piston assembly is in a middle position.Functional inspection showed there was no flow from the water source upon insertion of the feed line.The piston assembly was pulled to the upper position.The output was weak and pulsing.The pump cartridge assembly was opened, and the high-pressure valve ball was corroded with rust within it's fitting.The root cause is identified as corroded component.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.The complaint history file contains further instances related events of the reported event.This investigation is now complete with no further action deemed necessary.Smith and 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: 10248199
• MDR Text Key: 198076453
• Report Number: 8043484-2020-01772
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153555
• UDI-Public: 4582111153555
• Combination Product (y/n): N
• PMA/PMN Number: K143115
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• 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: 50808825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1