BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHROMATIC SCOPE, 5MM

    MDR report key: 362029 · Received November 21, 2001

    Report

    Report Number
    2953148-2001-00062
    Event Type
    Injury
    Date Received
    November 21, 2001
    Date of Event
    October 23, 2001
    Report Date
    November 21, 2001
    Manufacturer
    SCHOLLY FIBEROPTIC GMBH
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAD BEEN AN INCREASE IN PCO2 AND PA PRESSURE IN PATIENT, WHICH WAS MOST LIKELY DUE TO THE TRACKING OF THE CO2 THROUGH THE SUBCATANEOUS TISSUE WITH ABSORPTION OF THE CO2 THROUGH THOSE TISSUES INTO THE BLOOD STREAM. THE PCO2 WAS NOTICED WHILE THE BRANCES WERE BEING CUT. THE CASE HAS TO BE CONVERTED TO OPEN IN ORDER TO COMPLETE THE CASE. THE SUBCUTANEOUS EMPHYSEMA RESOLVED THE NEXT DAY. THE PATIENT WAS LAST REPORTED TO BE IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52943 ACHROMATIC SCOPE, 5MM ENDOSCOPE GCJ SCHOLLY FIBEROPTIC GMBH 11333 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention