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

Model Number 66800039

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Event Description

It was reported that the versajet unit was being primed for use and was making a strange noise.The internal fan was not running and hot smell was coming from the unit causing it not to work properly.No case involved.

Manufacturer Narrative

H3, g6: the device intended for use in treatment was returned for evaluation.A relationship between the reported event and device could not be established.A visual inspection was performed and showed the no damage to the device.Functional inspection was performed and showed the device functioned as intended.Overheating could not be replicated.The console was not noisy.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint history review found other related failures.Probable root cause may may have been an obstruction.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for adverse trends related to this product.

• 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: 10763878
• MDR Text Key: 213930997
• Report Number: 8043484-2020-03367
• Device Sequence Number: 1
• Product Code: FQH
• UDI-Device Identifier: 00040565124759
• UDI-Public: 00040565124759
• Combination Product (y/n): N
• PMA/PMN Number: K110958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• 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: 10/23/2020
• Date Manufacturer Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1