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

Catalog Number	ASC4251-01
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee arthroscopy the device overheated causing the plastic sheathing to melt.The procedure was successfully finished with the same device.No delay was reported.An injury was reported on the condyle (two imprints on non-weight bearing part).
Additional Manufacturer Narrative
The device, used for treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.Visual evaluation under magnification shows minimal electrode wear with a significant amount of discoloration present on the cap.There is discoloration on the shaft as well as damage to the black shrink tube which is most likely due to plasma etching.There are no manufacturing abnormalities visually observed with the returned wand.The wand was tested using a compatible controller and activated in saline solution at default and maximum settings in which ablation and coagulation performed as intended.At no time during activation, the tip exhibited ¿arcing¿ which would cause a burn.The suction line was tested and performed as intended.Functional testing concluded that there is no electrical disturbance related to the wand.The complaint could not be verified and the root cause could not be determined with confidence as the returned device performed as intended during functional evaluation.It is possible that the tip of the wand made contact with a metal object such as a cannula that has the potential to cause this type of failure.Also, when using wands, ensure adequate flow and circulation of saline solution to prevent unnecessary heating of the solution that may result in tissue damage or thermal injury.Outlines warnings and precautionary measures to adhere to during activation of the device.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: STARVAC 90 ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8848516
• Report Number: 3006524618-2019-00364
• Device Sequence Number: 14052652
• Product Code: GEI
• UDI-Device Identifier: 00817470001716
• UDI-Public: 00817470001716
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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 Expiration Date: 02/25/2022
• Device Catalogue Number: ASC4251-01
• Device Lot Number: 2028766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/31/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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