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

Model Number	HD SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUT
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.
Event or Problem Description
On 6/23/2023, it was reported by a sales representative via sems that an ar-3210-0021 hd synergyuhd4 c-mount camera head had a flickering image.The item was found defective during an unspecified procedure and was switched out with a working replacement.The case and patient were not affected.This occurred during use with no patient harm.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(no problem found) the evaluation did not identify any issues relevant to the reported event.

• Brand Name: HD SYNERGYUHD4 C-MOUNT CAMERA HEAD, 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: 17362486
• Report Number: 1220246-2023-07226
• Device Sequence Number: 12272473
• Product Code: GCJ
• UDI-Device Identifier: 00888867218239
• UDI-Public: 00888867218239
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 11/01/2024

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: HD SYNERGYUHD4 C-MOUNT CAMERA HEAD, AUT
• Device Catalogue Number: AR-3210-0021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2015
• 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