BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K LAPAROSCOPE, 30 DEG, 10 X 330MM

    MDR report key: 19558594 · Received June 18, 2024

    Report

    Report Number
    1220246-2024-05923
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    September 29, 2022
    Report Date
    June 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    GCJ
    UDI-DI
    00888867029729
    PMA / PMN Number
    K941541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    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. EVENT DESCRIPTION: IT WAS REPORTED THAT THE DISTAL END OF THIS OPTIC IS SHARP EDGED. THE REPORTED EVENT WAS CONFIRMED AS THE EVALUATION REVEALED THAT THE WEDGE ON THE DISTAL END PROTRUDES SLIGHTLY. THIS IS TYPICALLY CAUSED BY A LARGE NUMBER OF HEATING AND COOLING CYCLES, THE WEDGE CAN MOVE SLIGHTLY AT THE DISTAL END AND THUS PROTRUDE, CAUSING THE MENTIONED "SHARP-EDGEDNESS". THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO WEAR AND TEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISTAL END OF THIS OPTIC IS SHARP EDGED. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262681 4K LAPAROSCOPE, 30 DEG, 10 X 330MM LAPAROSCOPE GCJ ARTHREX, INC. 4K LAPAROSCOPE, 30 DEG, 10 X 330MM 00888867029729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown