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

Catalog Number 66800039

Device Problems Defective Component (2292); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/1901

Event Type  malfunction  

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 and showed the light ring is damaged.Functional inspection was performed and showed the console powers up fine.Motor would not run when footswitch is pressed.Root cause is determined to be contact with another source & nbsp.A review of the manufacturing records found that there was no evidence that the product didn¿t meet specifications at the time of manufacture & nbsp.This investigation is now complete with no further action deemed necessary.

Event Description

It was reported that during evaluation the front bezel gasket and interface input gasket of the device were found damaged.No harm or injury reported.After investigation it was noticed that the motor would not run when footswitch is pressed.

Manufacturer Narrative

The device, 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 and confirms the front bezel gasket and interface gasket damage.Functional inspection was performed and showed the console powers up fine but would not activate when the footswitch was pressed.Root cause is determined to be contact with another source and a motor failure.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.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 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: 11787882
• MDR Text Key: 249437415
• Report Number: 8043484-2021-01010
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1