MAUDE Adverse Event Report: ARTHROCARE CORP. 3.5MM 90 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC1340-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the device overheats.No delay or patient injuries were reported.A back up was available to complete the procedure.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.Visual evaluation under magnification shows minimal electrode wear with dried tissue present on the spacer and electrodes.Further visual evaluation with an unaided eye found no manufacturing abnormalities with the returned device.The wand was connected to a compatible controller and activated in saline solution at the default and max settings on the controller in which the ablate and coagulation performed as intended.At no time during functional testing the device overheated.The complaint could not be verified as the returned device functionally performed as intended.The root cause could not be determined with confidence as several factors could contribute to the reported event such as: having inadequate flow and circulation of saline, secondary source of outflow was not used or pre-warmed saline may have been used.The instructions for use provided with the device contains warnings and precautionary measures related to proper use of the device.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: 3.5MM 90 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8883760
• Report Number: 3006524618-2019-00391
• Device Sequence Number: 2716621
• Product Code: GEI
• UDI-Device Identifier: 00817470001839
• UDI-Public: 00817470001839
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K033584
• 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): 09/17/2019

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 Expiration Date: 02/02/2022
• Device Catalogue Number: AC1340-01
• Device Lot Number: 2027154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1