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

Model Number	4K SYNERGYUHD4 C-MOUNT BB CAMERA HD, AUT
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3210-0030 camera got very hot.This was discovered during a case with no patient effect.
Additional Manufacturer Narrative
Customer complaint is not confirmed.The device was subjected to functional testing per wi-000102640 and failed centration.All other functional criteria were met.A touch temperature thermal test was performed for 2 hours per tp-02243-21 (plm42314).The maximum temperature of the device is 47.2c and meets the touch temperature limits per bs en 60601-1 2006+a12 2014, standards ( 48c) maximum touch temperature.The evaluation did not identify any issues relevant to the reported event.

• Brand Name: 4K SYNERGYUHD4 C-MOUNT BB CAMERA HD, AUT
• Common Device Name: LAPAROSCOPE
• 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: emily shafer ; 8009337001
• MDR Report Key: 17215445
• Report Number: 1220246-2023-06998
• Device Sequence Number: 16890389
• Product Code: GCJ
• UDI-Device Identifier: 00888867230316
• UDI-Public: 00888867230316
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 15006061
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown