MAUDE Adverse Event Report: ARTHREX, INC. SYNERGYRF¿ CONSOLE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number SYNERGYRF¿ CONSOLE

Device Problems Break (1069); Defective Device (2588)

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

Event Date 01/13/2022

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 surgery a deflagration occurred in the joint.The device ar-9811 (lot 2101252) is defect and the device ar-3350-4031 (sn: (b)(4)) was also damaged and is defect.It is unclear, if the error was caused by the probe ar-9811 or the console ar-9800 (sn: (b)(4)).No part of the devices broke off.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with a different device.It was not necessary to switch the surgical technique or do a second surgery.

Manufacturer Narrative

The complaint is not confirmed.(1) unpackaged ar-9800 was received for investigation.Upon visual inspection, no issues were found.Functional testing was performed, including dielectric strength, lf leakage current, and rf leakage current tests.All tests was passed successfully, and no problem was found with the investigated device.Refer to attached test datasheet for more information.

• Brand Name: SYNERGYRF¿ CONSOLE
• 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: 13397111
• MDR Text Key: 284870467
• Report Number: 1220246-2022-04360
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: 00888867142473
• 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,Followup
• Report Date: 08/02/2022

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: SYNERGYRF¿ CONSOLE
• Device Catalogue Number: AR-9800
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other