MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. VERSAJET II CONSOLE; LAVAGE, JET

Catalog Number 66800039

Device Problem Connection Problem (2900)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

It was reported that the hand-piece interface is not in the correct position.When the hand-piece is attempted to be inserted, it won't turn to the active/on position, as the piston appears to be stuck in the 'extended' position.The sales rep made several attempts to clear the piston, by deploying the foot pedal in quick bursts, but to no avail.The machine likely requires a quick look and repair from engineering.No patient was involved.

Manufacturer Narrative

The device that was intended for use in treatment was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed on the exterior of product and no physical damage was observed.Functional inspection was performed and showed the test pump cartridge was difficult to turn to the locked position due to corrosion inside u.I.Assembly.The root cause is determined to be caused by corrosion.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture.A complaint history review found other related failures.Smith and nephew will continue to monitor for any adverse trends relating to this product.No further investigation is required.

• Brand Name: VERSAJET II CONSOLE
• 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: 10431303
• MDR Text Key: 203672373
• Report Number: 8043484-2020-02551
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153524
• UDI-Public: 4582111153524
• 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,user facility
• 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: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1