MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that green stripes on the surgical monitor, intraoperative.There was no harm for the patient, operator or third party reported.Further information was requested.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
(head cable) the evaluation determined that the reported event was caused by a defective head cable.This was attributed to wear and tear.

• Brand Name: 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
• 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: 17408396
• Report Number: 1220246-2023-07333
• Device Sequence Number: 7121478
• Product Code: GCJ
• UDI-Device Identifier: 00888867216570
• UDI-Public: 00888867216570
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 BB CAMERA HEAD,AUTOCLAV
• Device Catalogue Number: AR-3210-0029
• Device Lot Number: 12902457
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• 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