BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHOLANGIOGRAM CLAMP

    MDR report key: 21571855 · Received March 11, 2025

    Report

    Report Number
    21571855
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    February 24, 2025
    Report Date
    February 27, 2025
    Manufacturer
    SYMMETRY SURGICAL INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING THE LAPAROSCOPIC PROCEDURE, DR. [REDACTED] AND THE SCRUB TECHS NOTICED THAT THE OLSEN CHOLANGIOGRAM GRASPER SCREW CAME OFF INSIDE THE PATIENT. ALL THREE PERSONNEL IDENTIFIED THE ISSUE AND WERE ABLE TO FIND THE SCREW AND TOOK IT OUT OF THE PATIENT. THE GRASPER HAD ANOTHER SCREW, WHICH WAS ATTACHED TO THE GRASPER. RN (REGISTERED NURSE) BROUGHT A STERILE OLSEN CHOLANGIOGRAM GRASPER FROM SPD [STERILE PROCESSING DEPARTMENT], AND THE MD (MEDICAL DOCTOR) COMPARED THE BROKEN ONE TO THE NEWLY OPEN ONE, AND MADE IT CERTAIN, THAT NOTHING OTHER THAN THE SCREW THAT CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1309600 CHOLANGIOGRAM CLAMP ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES GEI SYMMETRY SURGICAL INC. 91-5035

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male