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

Model Number	66800472
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8043484-2021-01800
• Device Sequence Number: 13881203
• Product Code: FGH
• UDI-Device Identifier: 00040565125473
• UDI-Public: 00040565125473
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1