BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4K LAPAROSCOPE, 30 DEG, 10 X 330MM

    MDR report key: 19483762 · Received June 7, 2024

    Report

    Report Number
    1220246-2024-05190
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 2, 2022
    Report Date
    June 7, 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 OPTICS IS SHARP-EDGED. THE REPORTED EVENT WAS CONFIRMED AS THE VISUAL EVALUATION REVEALED THE DISTAL END IS SHARP-EDGED DUE TO THE FACT THAT THE KEEL IS PROTRUDING OUT OF THE DISTAL ENDS. COMPLAINANT¿S EVENT IS TYPICALLY CAUSED IF THE CHANGING TEMPERATURES BUILT UP STRESS ON THE ENTIRE ENDOSCOPES DURING USAGE TIME THE HEATING AND COOLING DURING REPROCESSING LEADS TO EXTENSION AND CONTRACTION OF THE DIFFERENT MATERIALS. THIS STRESS CAN BE THE REASON FOR THE KEEL TO PROTRUDE OUT OF THE DISTAL END. FURTHER THE SHAFT IS SLIGHTLY BEND, THE DISTAL END HAS SCRATCHES AND THE ATTACHMENT FOR THE LIGHT GUIDE CABLE HAS SIGNS OF BURNS CAUSED BY EXCESSIVE HEAT. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO THE DAMAGE TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OPTICS 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
    1436661 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