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

Model Number	4K SYNERGYUHD4 C-MOUNT BB CAMERA HD, AUT
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	10/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was 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 during a diagnostic laparoscopy procedure, the patient got burned.The burn was discovered by the patient after the surgery.The following devices were used during the procedure: ss9-gyw50w108 / batch wo155094, ar-3210-0030, s/n (b)(4), ar-3210-0006, s/n (b)(4), ar-3351-5500, s/n (b)(4).No further information has been made available.
Additional Manufacturer Narrative
No problem found.The evaluation did not identify any issues relevant to the reported event for ar-3210-0030/(b)(6).

• Brand Name: 4K SYNERGYUHD4 C-MOUNT BB CAMERA HD, AUT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10422377
• Report Number: 1220246-2020-02060
• Device Sequence Number: 2991289
• Product Code: GCJ
• UDI-Device Identifier: 00888867230316
• UDI-Public: 00888867230316
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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, AUT
• Device Catalogue Number: AR-3210-0030
• Device Lot Number: 10243098
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other