BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIBLE ALLIGATOR GRASPER

    MDR report key: 2232207 · Received August 26, 2011

    Report

    Report Number
    MW5021923
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    August 25, 2011
    Report Date
    August 26, 2011
    Manufacturer
    STORZ
    Product Code
    HIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE ADMITTED ON THURSDAY (B)(6) 2011 FOR HYSTEROSCOPY. DURING THE PROCEDURE, THE TIP OF THE FLEXIBLE ALLIGATOR GRASPER DETACHED FROM THE END. IT MEASURES 1 CM IN LENGTH. THIS TIP IDENTIFIED AND REMOVED FROM THE SURGICAL SITE. THIS FLEXIBLE ALLIGATOR GRASPER WAS INSPECTED PRIOR TO THE PROCEDURE BY THE OPERATING ROOM TECH -FOUND TO BE INTACT AND FUNCTIONING AT THIS TIME-.THERE WAS NO NEGATIVE IMPACT ON PT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE ALLIGATOR GRASPER FLEXIBLE ALLIGATOR GRASPER HIH STORZ 97023FG 97023FG

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR