MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF HOOK, NON-ASPIRATING 90°; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	APOLLORF HOOK, NON-ASPIRATING 90°
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2019
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 requested/is expected but has 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 procedure, the apollo rf hook, ar-9825, would not heat up when on default setting.The facility then tried turning the apollo rf hook setting higher, and the hook would not heat.The facility then opened a new apollo rf hook and the same issue occurred, as the apollo rf hook would not heat on either settings.The surgeon the used scissors to cut across the tissue due to the 2 apollo rf hooks not working.No further information provided.

• Brand Name: APOLLORF HOOK, NON-ASPIRATING 90°
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8289527
• Report Number: 1220246-2019-00872
• Device Sequence Number: 19508422
• Product Code: GEI
• UDI-Device Identifier: 00888867142572
• UDI-Public: 00888867142572
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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: 03/31/2022
• Device Model Number: APOLLORF HOOK, NON-ASPIRATING 90°
• Device Catalogue Number: AR-9825
• Device Lot Number: S170131
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/30/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other