MAUDE Adverse Event Report: ARTHROCARE CORP. TURBOVAC 90 XL ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ASC1336-01
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	02/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that at the end of the procedure a burn injury was found in the left thigh of the patient.
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.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.The photo of the patient¿s lower leg has been submitted for review and show the wound in question.There are several factors that could contribute to the reported event such as: failure to attach the recommended suction properly and inadequate flow and circulation of saline could cause a patient burn.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: TURBOVAC 90 XL ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8516507
• Report Number: 3006524618-2019-00186
• Device Sequence Number: 11222594
• Product Code: GEI
• UDI-Device Identifier: 00817470006520
• UDI-Public: 00817470006520
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2019

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: ASC1336-01
• Device Lot Number: 2019288
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 100