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

Model Number	10863-59
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/1901
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the product wasn't producing any energy.It resulted in a 20 minute delay in the case while they opened medtronic debrider.No patient injuries were reported.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Factors which can lead to no power include: damage sustained to the foot control assembly cable which could have been caused by running over with another portable object/machine.Excessive tensile stress applied to the cable which could have partially broken one or more signal wires causing failure of the unit.There may have been a loose cable connection between the returned device and the used controller which could cause non-functionality of the device.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: FOOT CONTROL ASSEMBLY
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 6910616
• Report Number: 3006524618-2017-00300
• Device Sequence Number: 13573820
• Product Code: GEI
• UDI-Device Identifier: 00817470003970
• UDI-Public: (01)00817470003970(10)266221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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: 10863-59
• Device Catalogue Number: 10863
• Device Lot Number: 266221
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 09/28/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1