MAUDE Adverse Event Report: ARTHROCARE CORP. COBLATOR II CONTROLLER 240V; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EC8001-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the machine shut down.No back up device was available, no significant delay nor patient injuries was reported.
Additional Manufacturer Narrative
The returned controller, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship found between the reported incident and the returned device.Visual inspection shows no cosmetic issues on the controller.The back label and the warranty seal are in good condition.During the functional test, the device did not power up.The power input module is shows a broken effort, the fuses are blown.The device cannot be tested as there is an electrical component failure on the mainboard.The received cables and the foot switch were tested and performed as intended, there are no cosmetic issues found.The complaint was verified because the device could not be powered up.The root cause can be determined due to an electrical component failure on the mainboard.There are no indications to suggest the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The product was not returned for evaluation and had been intended to be used for treatment.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: 1.A power surge to the subject controller, 2.Using an improper power cord or improper extension cord, or a loose power connection, 3.Failure of an electronic component inside the subject controller.4.Improper power cycling of the subject controller.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: COBLATOR II CONTROLLER 240V
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8478900
• Report Number: 3006524618-2019-00163
• Device Sequence Number: 1471769
• Product Code: GEI
• UDI-Device Identifier: 00817470002164
• UDI-Public: 00817470002164
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030108
• 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,Followup
• Report Date (Section B): 11/01/2019

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: EC8001-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 10/30/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/10/2019; 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR