MAUDE Adverse Event Report: ARTHREX, INC. 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV; LAPAROSCOPE

Model Number	4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.(not confirmed) the evaluation did not reveal any issues relevant to the reported event.
Event or Problem Description
On 01/03/2022, it was reported by a sales representative via (b)(4) that a ar-3210-0029 camera head is overheating, and it is hot to the touch.This occurred during a case.There was no patient effect reported.
Additional Manufacturer Narrative
Additional information: g3, thermal test attachment added.

• Brand Name: 4K SYNERGYUHD4 BB CAMERA HEAD,AUTOCLAV
• 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: emily shafer ; 8009337001
• MDR Report Key: 19063714
• Report Number: 1220246-2024-01882
• Device Sequence Number: 12410418
• Product Code: GCJ
• UDI-Device Identifier: 00888867216570
• UDI-Public: 00888867216570
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/13/2024

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 BB CAMERA HEAD,AUTOCLAV
• Device Catalogue Number: AR-3210-0029
• Device Lot Number: 12556304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2021
• 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