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

Model Number	72290007
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
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.Incident occurred while setting-up to the procedure.A back-up device was available and no delays occurred.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.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.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).H10 h3, 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 an isolated event.A visual inspection observed a rusted base and chassis and the cable connector is damaged, the fins are stuck flared out.A functional evaluation revealed the unit cannot be tested due to the damaged cable connector.The complaint was verified.Factors, unrelated to the design or manufacture of the device which could have contributed to the complaint 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: 11614034
• Report Number: 3006524618-2021-00418
• Device Sequence Number: 19596046
• Product Code: GEI
• UDI-Device Identifier: 00885556618417
• UDI-Public: 00885556618417
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K011634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2021

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: 72290007
• Device Catalogue Number: 72290007
• Device Lot Number: 285830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/27/2021; 07/23/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/28/2021; 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1