MAUDE Adverse Event Report: ARTHROCARE CORP. 3.5MM 90 DEGREE ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	AC1340-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a new wand was opened and passed to the surgical table; it was connected to the quantum console, then, we started to use it in order to make coagulation in the lateral meniscus of the left knee patient; at the moment of activating the wand with the pedal, it burn the cartilage of the patient.Doctor asked to lower the coagulation level that is predetermined in the console, but at this moment, we noticed that the rf wand looked brown and it was releasing particles inside the patient's joint.No delay or patient injuries were reported.
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 since the device was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.

• Brand Name: 3.5MM 90 DEGREE ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 7489094
• Report Number: 3006524618-2018-00224
• Device Sequence Number: 334119
• Product Code: GEI
• UDI-Device Identifier: 00817470001839
• UDI-Public: (01)00817470001839(17)201031(10)2007497
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2018

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: 10/31/2020
• Device Model Number: AC1340-01
• Device Catalogue Number: AC1340-01
• Device Lot Number: 2007497
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Weight: 62