MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGY UHD4; LAPAROSCOPE

Model Number	CCU, ARTHREX SYNERGY UHD4
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
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
It was reported that the heat from light source is too much, its burns the light cable.The problem was noticed after the surgery.There was no harm for the patient, operator or third party reported.Also there was no case involvement reported.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint is not confirmed as the device was not received for evaluation, and no pictures of the failure were received.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex was able to conclude the most likely cause.The most likely reason for the reported failure is user error, specifically not paying attention to the warnings and recommendations in the directions for use.Dfu-0332.Warnings.26.Risk of burns! light emitting diode (led) light engines emit large amounts of light and thermal energy.As a result: always keep the led light engine in the standby mode when not in use.The endoscope light guide connection can get extremely hot as result of high intensity light, giving rise to high temperatures in front of the light emission window which may cause severe burns.Surface temperatures of the insertion portion of the endoscope as well as light guide connectors on the camera control unit (ccu) and the endoscope rise during use.Potential thermal injury to the patient¿s tissue and skin may result from prolonged exposure to the intense illumination in small cavities, or if the endoscope¿s distal end is placed in close proximity with the tissue.This can cause the temperature of the body tissue to rise in excess of 106 °f (41 °c).Burns or thermal damage to surgical equipment may also result.Avoid prolonged exposure to intense illumination.Use the minimum level of illumination necessary to satisfactorily illuminate the target area.Do not place the endoscope¿s distal end or light guide connector on the patient¿s skin, on flammable materials or on heat sensitive materials.Turn the light source off when detaching the endoscope from the light guide cable.27.Radiofrequency arthroscopes and laparoscopes: high frequency [hf] electrical surgical instruments may lead to severe patient injuries and/or damage to the endoscope.Care should be taken to ensure that the working element is kept within field of view to prevent accidental burns.A sufficient distance from the tip of the endoscope to other conductive accessories and instruments should be maintained (10 mm) before activating the hf output to prevent burns and damage to the endoscope.Refer to the hf surgical device instructions for proper and safe use.Spine endoscopes: when using spine endoscopes (ar-s3350-xxxx-xxx) refer to the appropriate device instructions for use for guidance on proper and safe use with hf electrical surgical instruments.

• Brand Name: CCU, ARTHREX SYNERGY UHD4
• 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: 19123703
• Report Number: 1220246-2024-02076
• Device Sequence Number: 18200193
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 01/29/2025

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: CCU, ARTHREX SYNERGY UHD4
• Device Catalogue Number: AR-3200-0021
• Device Lot Number: 1176518
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown