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

Model Number APOLLORF HOOK, NON-ASPIRATING 90°

Device Problem Arcing of Electrodes (2289)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/09/2024

Event Type  malfunction  

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 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.

• Brand Name: APOLLORF HOOK, NON-ASPIRATING 90°
• Type of Device: 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
• MDR Text Key: 336554762
• Report Number: 1220246-2024-01206
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

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