MAUDE Adverse Event Report: ARTHROCARE CORP. PROCISE XP COBLATOR II; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	EICA8872-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an inguinal and palatine tonsilectomy and at the end of the procedure it was noticed that one of the three wires of the wand was broken.Patient was admitted to the hospital overnight to be closely monitored for any post-operative complications.He was subsequently discharged.Based on the current available information no serious injury could be confirmed.Additional information will be requested.
Additional Manufacturer Narrative
Update to include user facility/importer report number.
Additional Manufacturer Narrative
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.Most likely, the wand reached the end of its useful life, as this will cause disintegration of the electrodes and appear as if the electrodes are broke.Factors unrelated to the design and manufacture of the device which could have contributed to the reported event includes extended ablation or use of power level settings above the recommended default levels.There were no indications that would suggest that the device did not meet product specification upon release into distribution.Device returned for evaluation.Device evaluated by the manufacturer.Evaluation codes updated.

• Brand Name: PROCISE XP COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7168503
• Report Number: 3006524618-2018-00015
• Device Sequence Number: 1043210
• Product Code: GEI
• UDI-Device Identifier: 00817470003727
• UDI-Public: (01)00817470003727(17)191231(10)2002163
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142999
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2018

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: No Information
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: EICA8872-01
• Device Lot Number: 2002163
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/03/2018; 03/11/2018
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 01/05/2018; 03/12/2018
• Patient Sequence Number: 1