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

Model Number	CCU, ARTHREX SYNERGY UHD4
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
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 (b)(6) 2024, it was reported by a sales representative via sems-06577322 that an ar-3200-0021 ccu console had a spark come from the unit.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Complaint not confirmed.Visual evaluation: the plate capacitor spring and the led button on the front panel were damaged prior to device return.No other issues were observed.Functional evaluation: ccu dbm180003 was subjected to functional testing per wi-000102861, fcl-ccu-ar-3200-synergy uhd4 final checklist using a known good test camera head and a known good test tablet.No functional issues were observed.Functional testing per wi-000102861, fcl-ccu-ar-3200-synergy uhd4 final checklist was repeated using the customer's returned tablet part number ar-3200-1013, serial number (b)(6).No functional issues were observed.Several test cases were created, and no functional issues were observed.The device was power cycled several times and reevaluated, and no functional issues were observed.The device was tested again while exercising the connection of the test camera head to the camera receptacle on the ccu, and no functional issues were observed.The device was subjected to an electrical safety test.The device passed the safety test, and no functional issues were observed.The top cover was removed and the unit was inspected for evidence of electrical burns and moisture intrusion.No evidence of thermal or moisture damage was observed.An additional test case was created, and the device successfully captured 4 images and 1 video.The test case ran for an additional 30 minutes, after which the case was ended.The 4 images and 1 video were successfully transferred to a usb drive and to an ipad.The reported event of "an ar-3200-0021 ccu console had a spark come from the unit" was not confirmed.

• 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: 19567679
• Report Number: 1220246-2024-06123
• Device Sequence Number: 14980627
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): 08/16/2024

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 UHD4
• Device Catalogue Number: AR-3200-0021
• Device Lot Number: 10259374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2018
• 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