BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLINE SURGICAL 1112 CLIP CARTRIDGE

    MDR report key: 22412607 · Received July 7, 2025

    Report

    Report Number
    MW5172285
    Event Type
    Injury
    Date Received
    July 7, 2025
    Report Date
    July 1, 2025
    Manufacturer
    MICROLINE SURGICAL, INC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DURING THE OPERATION, THERE WAS TISSUE BLEEDING AND THE TISSUE WAS CLAMPED WITH THE CONTINUOUS TITANIUM CLIP TO STOP THE BLEEDING. HOWEVER, THE HEMOSTATIC EFFECT WAS NOT GOOD. IT WAS FOUND THAT THE CLIP WAS NOT CLAMPED TIGHTLY AND DID NOT COMPLETELY CLOSE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153099 MICROLINE SURGICAL 1112 CLIP CARTRIDGE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MICROLINE SURGICAL, INC 1112

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown