MAUDE Adverse Event Report: ARTHROCARE CORP. BEVEL 45 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC2430-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery a spark jumped from the tip of the device, at the same time the screen of the anesthesia monitor turned off.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was no relationship found between the device and the reported incident.The visual inspection shows extensive electrode wear with contamination/discoloration and scratch/scuff marks on the spacer and cap.There are no manufacturing abnormalities visually observed with the returned device.Upon functional evaluation the device was plugged in to a good known q2 controller (p/n 28168-59) and was activated in a saline solution at default and maximum settings.Plasma at the tip of the wand was produced on the remaining electrodes.No manufacturing abnormalities nor the electrical short issue could be verified.The complaint was not verified but found the damaged electrode and the root cause could be determined to be expected wear/tear.

• Brand Name: BEVEL 45 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7512998
• Report Number: 3006524618-2018-00246
• Device Sequence Number: 1224585
• Product Code: GEI
• UDI-Device Identifier: 00817470004540
• UDI-Public: (01)00817470004540(17)201010(10)2007187
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2018

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: 10/10/2020
• Device Model Number: AC2430-01
• Device Catalogue Number: AC2430-01
• Device Lot Number: 2007187
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1