MAUDE Adverse Event Report: ARTHROCARE CORP. FOOT CONTROL ASSEMBLY; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 10863

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/13/2022

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an arthroscopy, the foot control assembly coagulation pedal got stuck keeping the system on continuously.The procedure was completed without a delay using the same device.No patient complications were reported.Patient current status is stable.

Manufacturer Narrative

H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus functional testing could not be performed.There was no way to determine if the device contributed to the reported event.Visual inspection of the customer provided picture shows a foot pedal from a top down view with rust seen around the chassis but provides no complaint related information.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.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.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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: FOOT CONTROL ASSEMBLY
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14604051
• MDR Text Key: 293466027
• Report Number: 3006524618-2022-00278
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470001976
• UDI-Public: 817470001976
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K030108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

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 Catalogue Number: 10863
• Device Lot Number: 311757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 07/18/2022
• Date Device Manufactured: 05/08/2017
• 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
• Patient Sex: Male