MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGYUHD4; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CCU, ARTHREX SYNERGYUHD4

Device Problem Overheating of Device (1437)

Patient Problems Complaint, Ill-Defined (2331); Electric Shock (2554)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that during the surgery the light guide cable became very hot.The nurse touched the head of the cable and suffered a burn.The other nurse wanted to remove the cable from the holder and received an electrical shock.The nurse did not have to be treated after the electric shock.The nurse with the burn did wear gloves so she has no burns on her skin.The incidents happened while the patient was still under anesthesia.However, the incident did not affect the surgery.The surgery was completed successfully.The light guide cable is a storz device, part number 495nd.Light guide cable was not distributed to customer via arthrex.Camera head ar-3210-0029 with sn (b)(4) was attached to ccu during incident.All devices (ccu, light guide cable, adapter and camera head) have been requested back for evaluation.Camera head, ccu and light guide cable to be returned.Two incidents happened during sugery.Hence, two individual complaints have been created to reflect these circumstances.(b)(4), which this report is being filed for, is to cover electrical shock of second nurse.(b)(4) is to cover burn of first nurse.

Manufacturer Narrative

The complaint was not confirmed.After further evaluation of the returned device, the complaint about a burn and electrical shock could not be replicated.The device performed as it is supposed to do.

• Brand Name: CCU, ARTHREX SYNERGYUHD4
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8375661
• MDR Text Key: 137362827
• Report Number: 1220246-2019-00920
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• Combination Product (y/n): N
• PMA/PMN Number: K153218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CCU, ARTHREX SYNERGYUHD4
• Device Catalogue Number: AR-3200-0021
• Device Lot Number: 10203958
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/05/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other