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

Model Number	CCU, ARTHREX SYNERGY ID
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 05/23/2024, it was reported by a sales representative via sems-06577733 that an ar-3200-0025 synergy ccu's led lamp went out during a procedure.No patient harm reported.
Additional Manufacturer Narrative
(light engine) this evaluation determined that the reported event occurred due to a failing light engine.

• Brand Name: CCU, ARTHREX SYNERGY ID
• 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: 19568519
• Report Number: 1220246-2024-06168
• Device Sequence Number: 6305913
• Product Code: GCJ
• UDI-Device Identifier: 00888867351189
• UDI-Public: 00888867351189
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K202582
• 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
• Report Date (Section B): 06/19/2024

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: CCU, ARTHREX SYNERGY ID
• Device Catalogue Number: AR-3200-0025
• Device Lot Number: 13130750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown