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

Model Number CCU, ARTHREX SYNERGYUHD4

Device Problems Material Discolored (1170); Failure to Power Up (1476); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  Injury  

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 there was a smoke development at the synergy console, at the connector of the camera head during surgery.The device smelled charred and it was not able to turn on the device.Both affected items will be sent in ar-3200-0021 sn: (b)(4) and ar-3210-0018 sn: (b)(4).They also reported that the amount of smoke was so much that they had to remove the patient in the meantime from the operation room.Update 12-march-2019: they stopped the surgery, removed the patient and then brought back the patient later.

Manufacturer Narrative

Additional information has been added to the event description.Complaint confirmed.The device could not be powered on via the power cable or the power button.In an effort to identify the source of the problem, the interior of the device was examined (while connected to a power source).When light engine was disconnected from the power supply, the device immediately powered on.The returned light engine was replaced with a known, good light engine and testing was repeated.All functional requirements were met.The device was burned in for one hour.During that time, no device overheating was observed.The returned light engine was examined and the cause of failure was found to be a short from the 12v line to ground within the light engine circuitry.The reported event of 'a smoke development at the synergy console, at the connector of the camera head during surgery.The device smelled charred and it was not able to turn on the device' was therefore confirmed and attributed to a defective light engine.The device was evaluated by the manufacturer.The root cause of the light engine failure was attributed to a defective light engine.

Event Description

It was reported that there was a smoke development at the synergy console, at the connector of the camera head during surgery.The device smelled charred and it was not able to turn on the device.Both affected items will be sent in ar-3200-0021 sn: (b)(4) and ar-3210-0018 sn: (b)(4).They also reported that the amount of smoke was so much that they had to remove the patient in the meantime from the operation room.Update 12-march-2019: they stopped the surgery, removed the patient and then brought back the patient later.Update 04-april-2019: the surgery didn't last any longer, there was no harm for anybody.Nothing remain inside the patient.No new anaesthesia had to be given and the patient did not have to be taken out of the anaesthesia.Update 24-april-2019: the performed surgery was an shoulder arthroscopy.The surgery was completed successfully with a different device.It was not necessary to change the surgical technique or perform a second surgery.No adverse event reported by the customer.

• Brand Name: CCU, ARTHREX SYNERGYUHD4
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 8455317
• MDR Text Key: 139974002
• Report Number: 1220246-2019-00982
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

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: CCU, ARTHREX SYNERGYUHD4
• Device Catalogue Number: AR-3200-0021
• Device Lot Number: 10211741
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 03/06/2019
• Supplement Dates FDA Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other