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

Model Number 66800039

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Complaint number: case-(b)(4).

Event Description

It was reported that staff could not turn handpiece key once it was inserted into the versajet console.They tried several different handpieces but were unable to turn the handpiece key clockwise.Case was completed without the versajet, physician was only able to debride by hand by using a scalpel.No harm or injury reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device used in treatment was returned for evaluation.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 could not be turned to the locked position due to the corrosion inside u.I.Assembly, establishing a relationship between the device and report event.The root cause is determined to be traced to maintenance.The manufacturing records show no evidence that the product did not meet the specification at the time of manufacture.A complaint history review found further instances of the reported event.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional rmr is not required.Instructions for use contains recommendations and precautionary statements for proper use of product.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: 10876724
• MDR Text Key: 217428411
• Report Number: 8043484-2020-03948
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• 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
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800039
• Device Catalogue Number: 66800039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention