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

Catalog Number 66800472

Device Problem Defective Component (2292)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference:.

Event Description

It was reported that the footswitch, multi-function, versajet ii does not advance when pressing pedal or up and down knobs.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

H3, h6: the device was returned for evaluation, confirming the reported event.Visual inspection noted the strain relief where the cable enters the device is cracked/broken and shows the internal wires, the orange wire is severed at this spot.Functional evaluation confirmed the foot pedal error diode lights up when the device is plugged into a test versajet console, confirming the footswitch was defective.The root cause is determined as wear from use, causing the internal wire to break.A documentation investigation has been conducted, the device history confirmed that no manufacturing problems where observed.Complaint history shows previous events of this nature, with no historical escalations or corrective actions initiated.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no corrective actions deemed necessary at this time.

Manufacturer Narrative

H3, h6: the device was returned for evaluation, confirming the reported event.Visual inspection noted the strain relief where the cable enters the device is cracked and shows the internal wires.The orange wire is severed at this spot., functional evaluation confirmed the foot pedal error diode lights up when the device is plugged into a test versajet console.The device is inoperable.The root cause is determined as excessive force has been placed on the cable to footswitch assembly, causing the internal wire to break.A documentation investigation has been conducted, the device history confirmed that no manufacturing problems where observed.Complaint history shows previous events of this nature, with no historical escalations or corrective actions initiated.The instructions for use contain comprehensive instructions on the safe operation and use of the device.The risk files mitigate the reported issue with no updates required.Smith and nephew can confirm the device was released according to specifications and continue to monitor for adverse trends relating to this product range.This investigation is now complete with no corrective actions deemed necessary at this time.Additional information: d8/d9.

• 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
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13169051
• MDR Text Key: 284834611
• Report Number: 8043484-2022-00012
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800472
• Device Lot Number: 0684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1