MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH,VULCAN; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 7209692

Device Problems Overheating of Device (1437); Unexpected Shutdown (4019)

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

Event Date 06/08/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that during the set up for an unknown procedure, the cord wire of a vulcan footswitch warmed up and then the device stopped working.The procedure was successfully completed without delay using a back-up device.No patient complications were reported.

Manufacturer Narrative

H10: internal complaint reference: (b)(4).H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was no relationship found between the returned device and the reported event.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review found similar reported events.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The complaint was not confirmed.Factors, which could have contributed to the complaint event, include an electrical short in the cord.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• Brand Name: FOOTSWITCH,VULCAN
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14830631
• MDR Text Key: 302589618
• Report Number: 1643264-2022-00224
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 03596010470546
• UDI-Public: 03596010470546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 7209692
• Device Catalogue Number: 815002-01
• Device Lot Number: 328779
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/03/2022
• 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: Unknown
• Patient Sequence Number: 1