MAUDE Adverse Event Report: ARTHROCARE CORP. COVATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	AC4340-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery the ceramic part was detached from the tip of the wand.The piece did not remain in the patient.A backup device was available, no delay, no patient injury, the affected wand available.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the device and the reported incident.Visual inspection under magnification of the wand shows extensive wear at distal end.The plastic part of the spacer broke-off and is missing.There are no manufacturing abnormalities visually observed with the returned wand.Upon functional evaluation the device was plugged in to a good known q2 controller and was activated in a saline solution at default and maximum settings.Low plasma was produced at distal end as intended.The complaint was verified and the root cause could be determined with certainty.Factors which contribute to the reported event: the wand is designed for ablation and/or coagulation only, and not for mechanical displacement of tissue through applied force do not use the wand as a lever to enlarge a surgical site or gain access to tissue as this may result in a bent or detached electrode, damage to device, and/or a cracked spacer leading to patient injury.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: COVATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8881539
• Report Number: 3006524618-2019-00381
• Device Sequence Number: 11294771
• Product Code: GEI
• UDI-Device Identifier: 00817470003314
• UDI-Public: 00817470003314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2019

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 Catalogue Number: AC4340-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/10/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1