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

Model Number SYNERGYRF¿ CONSOLE

Device Problem Defective Component (2292)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2021

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 the surgery the fuse in the operating room failed.This error could be reproduced by switching on the device.Without the device, the error no longer occurred.According to the surgeon no harm for patient, operator or third party occurred.Although the surgery was aborted due to the error no second surgery was necessary.Update 03-aug-2021: it was reported that the patient was already anaesthetized when the error occurred.There is no information from the client whether the surgery will be repeated.No further information received from the customer.

Manufacturer Narrative

(transistors, thermistors, main board) this evaluation determined that the reported event occurred due to failing transistors and thermistors on the main board.The fuse failure described by the customer resulted from the high voltage output (390v) shorting to ground as a result of damage to main pcba components q1, q2, q5, q6, r1 and r2, as well as damage to thermistors rt1 and rt2, which would have otherwise limited the high voltage output.

• Brand Name: SYNERGYRF CONSOLE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12335660
• MDR Text Key: 267212199
• Report Number: 1220246-2021-03531
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00888867142473
• UDI-Public: 00888867142473
• Combination Product (y/n): N
• PMA/PMN Number: K161581
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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
• Device Lot Number: 12923083
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 07/29/2021
• Supplement Dates FDA Received: 10/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other