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

Catalog Number 66800039

Device Problem Connection Problem (2900)

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

Event Date 01/01/1901

Event Type  malfunction  

Manufacturer Narrative

The device that was used in treatment was returned for evaluation.There was a relationship between the reported event and the device.A visual inspection was performed and showed no damage.Functional inspection showed the u.I.Handpiece hard to turn.  root cause is determined to be a component failure.A review of the associated batch manufacturing records confirmed that the device met manufacturing specifications at the point of release. 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.

Event Description

It was reported that before treatment the device was found to be vibrating and noisy.During the device operation the hand piece rotated.After investigation it was noticed that the u.I.Handpiece was hard to turn.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 101 hessle road; hull east riding of yorkshire HU3 2-BN ; UK HU3 2BN ; 5123913905
• MDR Report Key: 11693411
• MDR Text Key: 246266910
• Report Number: 8043484-2021-00880
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 04582111153524
• UDI-Public: 4582111153524
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• 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: 04/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1