MAUDE Adverse Event Report: ARTHREX, INC. COOLCUT 45, BALL ELECTRODE, SJ; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	COOLCUT 45, BALL ELECTRODE, SJ
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a tfcc (triangular fibrocartilage complex) debridement the surgeon attempted to use two arthrex coolcut wands, ar-9808sj-45 (lot 1909099).Both wands would not create energy at 15/15 cut and coag.The patient was grounded and lr saline was used.After the issue occurred the surgeon opted to do a repair and made a small incision and used a standard device from another manufacturer without issue.
Additional Manufacturer Narrative
Complaint confirmed.Two unpackaged ar-9808sj-45 devices were received for investigation.No damage was noted to the cables or distal tips of either wand.Each ar-9808sj-45 was functionally tested with an ar-9600 console, pad, and sample saline.The console was set to 15 cut, 15 coag for each device.Throughout testing, neither device was responsive.This event is most likely the result of fluid ingress into the handles, resulting in the observed malfunction.

• Brand Name: COOLCUT 45, BALL ELECTRODE, SJ
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10417088
• Report Number: 1220246-2020-02048
• Device Sequence Number: 14188639
• Product Code: GEI
• UDI-Device Identifier: 00888867062764
• UDI-Public: 00888867062764
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K023986
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: COOLCUT 45, BALL ELECTRODE, SJ
• Device Catalogue Number: AR-9808SJ-45
• Device Lot Number: 1909099
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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