MAUDE Adverse Event Report: ARTHROCARE CORPORATION EVAC 70 XTRA HP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	EICA5874-01
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device sparked.
Additional Manufacturer Narrative
The returned devices, intended for use in treatment, were returned as mdr¿s for evaluation.There were a relationship found between the returned devices and the reported incident.Visual inspection of the returned magnum2 knotless implant om-1502 shows deployed devices.There are no manufacturing abnormalities visually observed with the returned instruments.The magnum2 knotless is a single used device and cannot be functional tested.An attempt was made to test the basic functions of this instrument.Rotating the suture ratchet knob performed as intended.Pressing down the lock button with a single squeeze of the black hand-lever activates the bone lock and detaches the implant as specified.The complaint was not verified and the root cause could not be determined with certainty.Factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: improper suture loading, excessive tensioning or improper alignment of the inserter handle with the bone hole.The instructions for use (ifu) 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 that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: EVAC 70 XTRA HP COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• MDR Report Key: 7851437
• Report Number: 3006524618-2018-00540
• Device Sequence Number: 13735622
• Product Code: GEI
• UDI-Device Identifier: 00817470004007
• UDI-Public: (01)00817470004007(17)210216(10)2010901
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K070374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: 02/16/2021
• Device Model Number: EICA5874-01
• Device Catalogue Number: EICA5874-01
• Device Lot Number: 2010901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1