BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE EXTENDER FOR ADULT LARYNGOSCOPE

    MDR report key: 338529 · Received June 14, 2001

    Report

    Report Number
    1519132-2001-00043
    Event Type
    Malfunction
    Date Received
    June 14, 2001
    Date of Event
    May 11, 2001
    Manufacturer
    CIRCON ACMI
    Product Code
    EQN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN EXPERIENCED A DIFFICULT INTUBATION. HE USED A BLADE EXTENDER (LAR-AE) ON THE LARYNGOSCOPE BLADE AND THE PROCEDURE CONTINUED WITHOUT INCIDENT. SEVERAL WEEKS LATER THE PT EXPERIENCED STOMACH PAINS. IT WAS DISCOVERED THAT THE LAR-AE HAD FALLEN OFF DURING THE PROCEDURE AND WAS IN THE PT'S STOMACH. REPORTEDLY, THE PHYSICIAN STATED THAT HE PROBABLY HAD NOT SNAPPED THE LAR-AE ON THE LARYNGOSCOPE BLADE TIGHTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27254 BLADE EXTENDER FOR ADULT LARYNGOSCOPE BLADE EXTENDER EQN CIRCON ACMI LAR-AE NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO ADULT BULLARD ELITE LARYNGOSCOPE.