MAUDE Adverse Event Report: ARTHREX, INC. APOLLO RF 90° MULTIPORT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number APOLLO RF 90° MULTIPORT

Device Problems Patient Device Interaction Problem (4001); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 10/21/2021

Event Type  Injury  

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

It was reported that during a latarjet-surgery the electrode touched the metal part of the wire and the electrode gave the patient and the surgeon an electric shock.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.No further information received.

Manufacturer Narrative

The complaint is confirmed.(1) unpackaged ar-9811 was received for investigation.Upon visual inspection, it was noted that the device has signs of usage, with damage and scratch marks on the electrode.Functional testing revealed a probe memory failure warning, and an error of corrupted memory (crc, exit error code 3).Due to the signs of damage and the complaint allegation of touching a metal wire, the probable cause of the failure can be attributed to misuse, resulting in an impact with a metallic object, and subsequently shorting the device.Per dfu: "do not contact metal objects while the rf probe is activated, as this may cause damage to the rf probe.".

• Brand Name: APOLLO RF 90° MULTIPORT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 12851126
• MDR Text Key: 281139519
• Report Number: 1220246-2021-03962
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867248243
• UDI-Public: 00888867248243
• Combination Product (y/n): N
• Reporter Country Code: UP
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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
• Device Operator: Health Professional
• Device Model Number: APOLLO RF 90° MULTIPORT
• Device Catalogue Number: AR-9811
• Device Lot Number: 2012034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other