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	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: (not confirmed) the evaluation did not reveal any issues relevant to the reported event.
Event or Problem Description
On 05/17/2022, it was reported by a sales representative via sems that (2) ar-3210-0030 camera heads are malfunctioning, one is getting stuck as the other is getting hot.This was discovered during an unknown time, with no patient effect reported.

• 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: 19004468
• Report Number: 1220246-2024-01734
• Device Sequence Number: 20943895
• Product Code: GCJ
• UDI-Device Identifier: 00888867230316
• UDI-Public: 00888867230316
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/29/2024

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: 14913072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown