MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. FOOTSWITCH, MULTI-FUNCTION, VERSAJET II; CATHETER, DOUBLE LUMEN FEMALE URETHROGRAPHIC

Model Number 66800472

Device Problem Break (1069)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Internal reference number: (b)(4).

Event Description

It was reported that the foot pedal cord of a versajet ii multifunction footswitch is broken at the strain relief of the pedal end, it needs to be repaired or exchange the foot pedal.As this happened in a non-therapeutic environment, there was not patient involvement.

Manufacturer Narrative

H6: the device, intended for use in treatment, was returned for evaluation.The visual inspection of the returned device noted bare wiring on the cord, and the functional evaluation revealed that the footswitch would not activate the console, establishing a relationship between the device and the reported event.The root cause was identified as wear and tear.The device should never be used when, bare wires are exposed.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.A complaint history review found further instances of the reported 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.

• Brand Name: FOOTSWITCH, MULTI-FUNCTION, VERSAJET II
• Type of Device: CATHETER, DOUBLE LUMEN FEMALE URETHROGRAPHIC
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 12543664
• MDR Text Key: 273683829
• Report Number: 8043484-2021-01800
• Device Sequence Number: 1
• Product Code: FGH
• UDI-Device Identifier: 00040565125473
• UDI-Public: 00040565125473
• 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
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66800472
• Device Catalogue Number: 66800472
• Device Lot Number: 02980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1