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U.S. Department of Health and Human Services

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

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ARTHREX, INC. CCU, ARTHREX SYNERGYUHD4; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
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.
 
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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 Key8455317
MDR Text Key139974002
Report Number1220246-2019-00982
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier00888867197022
UDI-Public00888867197022
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K153218
Number of Events Reported1
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 NumberCCU, ARTHREX SYNERGYUHD4
Device Catalogue NumberAR-3200-0021
Device Lot Number10211741
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/06/2019
Initial Date FDA Received03/27/2019
Supplement Dates Manufacturer Received03/06/2019
Supplement Dates FDA Received08/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2018
Is the Device Single Use? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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