MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 C-MOUNT BB CAMERA HD,AUTO; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	4K SYNERGYUHD4 C-MOUNT BB CAMERA HD,AUTO
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device is expected but was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported the camera ar-3210-0030 got very hot during a knee scope and burned the surgeon's hand.The case was completed with a minor delay.He was holding on the grey metal portion of the camera.After the case he revealed a blister on his hand and it was considered to be a second degree burn.No rep was present at the case.It was noted that the doctor performed the rest of his cases that day without additional issues.
Additional Manufacturer Narrative
The evaluation concluded that the device met product and safety specifications.

• Brand Name: 4K SYNERGYUHD4 C-MOUNT BB CAMERA HD,AUTO
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7738581
• Report Number: 1220246-2018-00580
• Device Sequence Number: 1618570
• Product Code: GCJ
• UDI-Device Identifier: 00888867230316
• UDI-Public: 00888867230316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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
• Operator of Device: Health Professional
• Device Model Number: 4K SYNERGYUHD4 C-MOUNT BB CAMERA HD,AUTO
• Device Catalogue Number: AR-3210-0030
• Device Lot Number: NB
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/01/2018
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other