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	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(no problem found) the evaluation did not identify any issues relevant to the reported event.
Event or Problem Description
On 4/19/2024, it was reported by a sales representative via (b)(4)that an ar-3200-0021 synergyuhd4 camera control unit was overheating and got very hot and burned through the light guides and a staff member's clothing.It was stated that the staff member was not hurt, and the light guides were a non-arthrex product.This was discovered during a procedure, with no reported patient harm.Additional information was received on 4/29/2024: this was discovered during a ureteroscopy procedure on (b)(6) 2024.It was stated that the event was a "near miss" event.The or tech's gown had two burn holes caused by the end of the light cable after it was removed from the ccu.Nothing else was plugged into the ccu at the time of the event.The end of the light source was too hot to touch and looked scorched.Only a burning smell came from the or tech's gown.The case was completed as planned before identifying the light cable issue (the end of the light source had scorch marks that could not be removed during processing in spd; therefore, there are concerns about overheating and the ccu).There was no delay in the case or adverse effects due to this being a "near miss" event.No photos were taken.

• 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: 19343403
• Report Number: 1220246-2024-03455
• Device Sequence Number: 8966461
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 05/17/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Initial Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• 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