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

Model Number	72290007
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the wired foot pedal was not working.No case involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h6: the reported device, intended for use in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 concluded this was a repeat issue.A visual inspection was performed and found that the cable connector is damaged.A functional evaluation was performed and that the unit could not be tested due to the damaged cable connector.The complaint was verified.Factors that could have contributed to the reported event include misalignment of the connector when connecting to the unit receptacle in which excessive force or twisting could cause damage.No containment or corrective actions are recommended at this time.

• Brand Name: WIRED FOOT PEDAL
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 11572545
• Report Number: 3006524618-2021-00383
• Device Sequence Number: 3459722
• Product Code: GEI
• UDI-Device Identifier: 00885556618417
• UDI-Public: 00885556618417
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 72290007
• Device Catalogue Number: 72290007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1