MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 ULTRA, AUTOCLAVABLE
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 02/26/2024, it was reported by a sales representative via (b)(4) that an ar-3210-0031 camera appeared to have a short in it.No case involvement.
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 ULTRA, AUTOCLAVABLE
• 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: jared engle ; 8009337001
• MDR Report Key: 18869743
• Report Number: 1220246-2024-01386
• Device Sequence Number: 2970703
• Product Code: GCJ
• UDI-Device Identifier: 00888867279315
• UDI-Public: 00888867279315
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/15/2024

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, AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0031
• Device Lot Number: 14958011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2022
• 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