MAUDE Adverse Event Report: ARTHREX INC. COOLCUT 90,ASPIRATING ABLATOR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	AR-9803A-90
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.An evaluation of the device cannot be performed as the device was not yet returned to arthrex.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.The cause of the event is undetermined.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that when the hospital medical device (opes) was activated in the articular cavity of the patient's left shoulder, the arthroscopic tower monitor showed flames and sparks leaving the curvature of the distal tip of the radiofrequency tip.It was observed that in this curvature the plastic protection failed.At this time, no new information was received.

• Brand Name: COOLCUT 90,ASPIRATING ABLATOR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7502460
• Report Number: 1220246-2018-00173
• Device Sequence Number: 283758
• Product Code: GFF
• UDI-Device Identifier: 00888867062726
• UDI-Public: 00888867062726
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: AR-9803A-90
• Device Lot Number: 1701057
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/10/2018
• 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