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

Catalog Number AC4340-01

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during an unknown procedure, the black end of the wands cracked.The procedure was completed with a backup device with no delay or patient injury reported.

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.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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8755881
• MDR Text Key: 150278753
• Report Number: 3006524618-2019-00316
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003314
• UDI-Public: 00817470003314
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2021
• Device Catalogue Number: AC4340-01
• Device Lot Number: 2019175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1