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

Catalog Number	AC4340-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a knee ask procedure, the device tip was torn during normal use.There are no parts left in the patient.A backup device was available to complete the procedure with no delay and no patient injuries.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation.A relationship, if any, between the subject devices and the reported event could not be determined since the products were not returned for evaluation.Visual inspection and functional testing could not be performed because the devices in question were not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the products associated with this event are returned at a future date, this evaluation will be reopened for investigation.Factors not associated with the manufacture or design of the devices which could result in damage to the tips could be the devices coming into abrupt contact with a hard (metallic) object, improper insertion or removal from an apparatus, or excessive force applied to the tips can also lead to unintended detachment and are outlined in the precautionary statements in the instruction for use.There were no indications during manufacturing record review that would suggest that the devices 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: 8500395
• Report Number: 3006524618-2019-00176
• Device Sequence Number: 11411614
• Product Code: GEI
• UDI-Device Identifier: 00817470003314
• UDI-Public: 00817470003314
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/27/2019

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: 05/02/2021
• Device Catalogue Number: AC4340-01
• Device Lot Number: 2014606
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 26 YR