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

Catalog Number	EICA8875-01
Health Effect - Clinical Code	Blood Loss (2597)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a tonsillectomy procedure, the patient experienced a post-operative rebleed.All further information is still unknown.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.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 because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.Factors that could have led to post-operative bleeding includes: health and the patient's compliance to post-op instructions, types of food consumed, certain medicines and/or bleeding disorders that are known to reduce the body¿s ability to clot.

• Brand Name: PROCISE EZ VIEW COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8620233
• Report Number: 3006524618-2019-00237
• Device Sequence Number: 16665812
• Product Code: GEI
• UDI-Device Identifier: 00817470004335
• UDI-Public: 00817470004335
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EICA8875-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2019
• Supplement Date Received by Manufacturer: 05/15/2019; 06/20/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 05/21/2019; 06/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATALOG NUMBER: 13546-01.SERIAL NUMBER: (B)(4).
• Outcome Attributed to Adverse Event: Other