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

Model Number	EICA8898-01
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an adenoidectomy, it was reported that the surgeon was unable to successfully ablate down the tissue without massive clogging and bleeding in order to remove the adenoids.The case took over 1.5 hours where it should¿ve taken about 30 minutes.No patient injury was reported.The procedure was completed with a competitor device.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: 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.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.Please refer to the instructions for use for recommendations on suction usage.A review of risk management files found that the reported failure was documented appropriately.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.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: 1) it is possible that the suction line was not properly connected.2) the suction pressure used may have not supplied enough pressure in order to excavate blood and tissue.There are no indications to suggest the device did not meet product specifications upon release into distribution.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: PROCISE MAX COBLATOR II
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10694695
• Report Number: 3006524618-2020-00895
• Device Sequence Number: 19777485
• Product Code: GEI
• UDI-Device Identifier: 00817470003888
• UDI-Public: 00817470003888
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: EICA8898-01
• Device Catalogue Number: EICA8898-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 10/17/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention