BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGIVNEY HEMO LIGATOR 7

    MDR report key: 2338913 · Received November 4, 2011

    Report

    Report Number
    2523190-2011-00080
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    September 12, 2011
    Report Date
    November 4, 2011
    Manufacturer
    INTEGRA, YORK - IMILTEX
    Product Code
    EXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE NURSE REPORTED THAT THE HEMORRHOID LIGATOR "FELL APART AT THE START OF A PROCEDURE WHILE LOADING A RUBBER BAND" FOR A HEMORRHOID LIGATION. THERE WAS NO PT INJURY; THE PT DID NOT RECEIVE ANESTHESIA. THE PT RECEIVED ANTIBIOTICS AND A BOWEL PREPARATION PRIOR TO THE PROCEDURE. THE PROCEDURE WAS CANCELLED AND WILL BE RESCHEDULED AS THE PHYSICIAN DID NOT HAVE A SPARE DEVICE TO USE TO PERFORM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGIVNEY HEMO LIGATOR 7 M17 - RECTAL EXX INTEGRA, YORK - IMILTEX

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR