MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. FOOTSWITCH, MULTI-FUNCTION, VERSAJET II; LAVAGE, JET

Catalog Number 66800472

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/11/2020

Event Type  malfunction  

Event Description

It was reported that the cable was found broken and console doesn¿t recognize the foot pedal.No case involved.

Manufacturer Narrative

The device, intended for use in treatment, has been returned for evaluation, visual inspection reported exposed wire damage, the functional evaluation found the device failed to communicate the transmission for the foot pedal establishing a relationship between the device and the reported events.The root cause identified as component failure due to cable strained, we could not verify the lot number but we have no reason to believe that the product did not meet the specification at the time of manufacture.A complaint history review found other related events.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

Manufacturer Narrative

The device intended to be used in treatment has not been returned for evaluation, with no additional information provided we have not been able to establish a relationship between the device and the reported event or determine a root cause on this occasion.Factors that can contribute to the reported event include, damage, or obstruction, the instructions for use provide comprehensive instructions of the operation, use and limitations of the device.A dhr review was not performed because the lot number provided was inaccurate.The complaint history file contains further instances of the reported event.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: FOOTSWITCH, MULTI-FUNCTION, VERSAJET II
• 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: 10239643
• MDR Text Key: 197791830
• Report Number: 8043484-2020-01722
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800472
• Device Lot Number: 04893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Date Manufacturer Received: 08/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1