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	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
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 head screen was showing static lines with a red hue during a case.The case was completed by using another camera head.This was discovered during an unspecified procedure, with no patient harm.
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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.(prism) the evaluation determined that the reported event was caused by a defective prism.This was attributed to wear and tear.

• 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: 17304628
• Report Number: 1220246-2023-07114
• Device Sequence Number: 6506194
• Product Code: GCJ
• UDI-Device Identifier: 00888867230316
• UDI-Public: 00888867230316
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 10/31/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• 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