BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX. INTUBATION VIDEO SCOPE, 5.5 X 65CM

    MDR report key: 9869246 · Received March 23, 2020

    Report

    Report Number
    9610617-2020-00038
    Event Type
    Malfunction
    Date Received
    March 23, 2020
    Report Date
    August 11, 2022
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    CAL
    UDI-DI
    04048551421598
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA IN SECTION H6 HAVE BEEN CORRECTED TO MATCH THE EVALUATION FINDINGS.

    Additional Manufacturer Narrative · 0

    THE ENDOSCOPE HAS BEEN SENT IN WITHOUT INFORMATION ABOUT AN INCIDENT - DURING INSPECTION, WE WERE NOT ABLE TO DETECT ANY MALFUNCTION AT ALL. IT SHOWS SIGNS OF USE, BUT IS FULL FUNCTIONABLE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS NOT RESPONDED TO KST ATTEMPTS TO GATHER FURTHER INFORMATION. THE PRODUCT HAS NOT RETURNED FOR EVALUATION AT THIS TIME.

    Description of Event or Problem · 1

    PER THE FACTORY IN (B)(6), ALLEGEDLY THERE WAS AN EVENT THAT AN EMERGENCY VIDEO BRONCHOSCOPY WAS BEING PERFORMED DUE TO OBSTRUCTED AIRWAYS (ACUTE BLEEDING). THE SCREEN WENT BLACK/ FAILED DURING THE EXAMINATION. A REPLACEMENT HAD TO BE FOUND PROMPTLY. REPLACEMENT OF THE MEDICAL DEVICE WAS DONE. THE COAGEL WAS SUCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333849 FLEX. INTUBATION VIDEO SCOPE, 5.5 X 65CM INTUBATION FLEXIBLE VIDEO SCOPE CAL KARL STORZ SE & CO. KG 11303BNX 04048551421598

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown