BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTOSCOPES, SIGMOIDOSCOPES, ACC.

    MDR report key: 6098767 · Received November 14, 2016

    Report

    Report Number
    6098767
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 10, 2016
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    FAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    WHILE REMOVING THE VIDEO SIGMOIDOSCOPE FROM THE LIGHT SOURCE, THE SIGMOIDOSCOPE BODY SEPARATED FROM THE LIGHT SOURCE CONNECTION AND THE FLEXIBLE ENDOSCOPE SHEATH. THIS IS THE SECOND OCCURRENCE OF THIS TYPE OF FAILURE ON THIS SIGMOIDOSCOPE MODEL. REVIEW WITH THE USER INDICATED THAT THEY DID FOLLOW CORRECT REMOVAL PROCEDURE. THIS SCOPE WAS THE EXCHANGE SCOPE REPLACING A SCOPE THAT HAD THE SAME DAMAGE WITH SEPARATION OF THE LIGHT CONNECTOR BODY AND FLEXIBLE SHEATH. MANUFACTURER RESPONSE FOR VIDEO SIGMOIDOSCOPE, (BRAND NOT PROVIDED) (PER SITE REPORTER: MANUFACTURER NOTED THIS WAS A WARRANTY DEVICE DELIVERED TWO MONTHS AGO. MANUFACTURER CALLED UNIT IN. BIOMEDICAL ENGINEERING IS REQUESTING REPORT ON FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750603 PROTOSCOPES, SIGMOIDOSCOPES, ACC. SIGMOIDOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FAM KARL STORZ ENDOSCOPY-AMERICA, INC. 13901NKS

    Patients

    Seq Age Sex Outcome Treatment
    1