MAUDE Adverse Event Report: ARTHROCARE CORP. 2.3MM SHORT BEVEL 35 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC2823-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 2.3mm short bevel 35 degree icw, used in treatment, was returned for evaluation.A relationship between the device and reported incident was established.From the information provided, ¿during an ankle procedure, the device tip started to melt.¿ visual inspection under magnification shows extensive wear on the electrodes.There are missing sections of epoxy insulation around the spacer.No manufacturing discrepancies observed.During functional evaluation the device was plugged to a q2 controller and activated in saline solution at default and max.Settings.The device generated plasma intermittently.The complaint has been verified as the device tip is severely damaged.It usually happens when the outer surface of the cap has a crack or hole either caused by the end user or an electrical short inside the cap.The electrical short happens with saline ingress when either the epoxy insulation around the spacer has peeled off or the insulation is compromised with the cap failure at the tip of the wand.The instruction for use was reviewed and found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during an ankle procedure, the device tip started to melt.A backup device was available to complete the procedure with no delay and no patient injuries.Results of investigation have concluded that there were missing sections of epoxy insulation around the spacer, and potentially these pieces might fall into the patient which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: 2.3MM SHORT BEVEL 35 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 9334923
• Report Number: 3006524618-2019-00560
• Device Sequence Number: 1951303
• Product Code: GEI
• UDI-Device Identifier: 00817470004564
• UDI-Public: 00817470004564
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Report Date (Section B): 11/18/2019

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: 09/03/2021
• Device Catalogue Number: AC2823-01
• Device Lot Number: 2019278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1