MAUDE Adverse Event Report: ARTHREX, INC. APOLLORF HOOK, NON-ASPIRATING 90°; ELECTROSURG CUT/COAG DEVICE

Model Number	APOLLORF HOOK, NON-ASPIRATING 90°
Medical Device Problem Codes	Arcing of Electrodes (2289); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Malfunction
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a knee arthroscopy the plasma field formed, not only at the hook probe, but also at the entire tip of the probe.The surgeon then stopped using the probe for the operation because it was too risky for him.There was no harm for patient, operator or third party reported.The surgery was finished successfully.It was not necessary to switch the surgical technique or do a second surgery.Update nroe 13-feb-2024: further information revealed that the surgeon used the same device to finish the surgery, knowing that the plasma field was larger than usual.
Additional Manufacturer Narrative
Complaint allegation is not confirmed.One unpackaged ar-9825 apollo batch: 2206130 was returned for investigation.Visual inspection noted no problems with the device.The device was tested before the memory was cleared and the screen showed, ¿probe already used/replace probe.¿ after the memory was cleared, functional testing was performed with saline water and the probe worked as intended.The plasma field was observed to only form on the hook of the device.No problem found.

• Brand Name: APOLLORF HOOK, NON-ASPIRATING 90°
• Common Device Name: ELECTROSURG CUT/COAG DEVICE
• 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: jared engle ; 8009337001
• MDR Report Key: 18807196
• Report Number: 1220246-2024-01206
• Device Sequence Number: 7342220
• Product Code: GEI
• UDI-Device Identifier: 00888867142572
• UDI-Public: 00888867142572
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: APOLLORF HOOK, NON-ASPIRATING 90°
• Device Catalogue Number: AR-9825
• Device Lot Number: 2206130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown