MAUDE Adverse Event Report: ARTHREX, INC. HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Additional information has been added to the event description.Complaint was not confirmed.The device was tested and functional requirements were met.The device was burned in for four hours.After burn-in, three temperature readings were taken and they all met specifications.The device was also tested with ar-3200-0021, sn: (b)(4) (refer to mdr case-2019-18635-1).The evaluation found that the root cause of the issue associated with the reported event was not related to camera head (b)(4).The reported event of '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.
Event or Problem 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: HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8457834
• Report Number: 1220246-2019-00983
• Device Sequence Number: 3057123
• Product Code: GCJ
• UDI-Device Identifier: 00888867224056
• UDI-Public: 00888867224056
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0018
• Device Lot Number: NB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 08/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other