MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while connecting the camera head with the 4k console no live video was visible.It showed a pink image with multiple spikes.Additionally, it was stated that buttons are not working.There was no harm for patient, operator or third party reported.No further information received.
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
(head cable) the evaluation confirmed the reported event, "it was reported that while connecting the camera head with the 4k console no live video was visible.It showed a pink image with multiple spikes.Additioanly it was stated that buttons are not working.There was no harm for patient, operator or third party reported.No further information received." and attributed to abnormal use (unauthorized repair).

• Brand Name: 4K SYNERGYUHD4 ULTRA C-MOUNT, AUTOCLAVAB
• 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: 17324990
• Report Number: 1220246-2023-07161
• Device Sequence Number: 14863338
• Product Code: GCJ
• UDI-Device Identifier: 00888867276505
• UDI-Public: 00888867276505
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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 ULTRA C-MOUNT, AUTOCLAVAB
• Device Catalogue Number: AR-3210-0032
• Device Lot Number: 10221250
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• 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