BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 3193020 · Received June 10, 2013

    Report

    Report Number
    9610617-2013-00022
    Event Type
    Other
    Date Received
    June 10, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    EOQ
    PMA / PMN Number
    H040005
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE ALSO LEARNED LATER THAT AFTER THIS PROCEDURE TWIN B WAS TERMINATED DUE TO CONDITION AS WELL AS ANOTHER FETUS IN A SEPARATE SACK. THE HOSPITAL REPORTED THAT THERE WAS NO MALFUNCTION OF INSTRUMENTATION AND THAT DEVICES HAD NO IMPACT ON OUTCOME. THE TTTS SET IS NOT RETURNING.

    Description of Event or Problem · 1

    PLEASE REFER IMPORTER REPORT - (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262143 KARL STORZ RIGID TTTS FETOSCOPY INSTRUMENTS EOQ KARL STORZ GMBH & CO. KG

    Patients

    Seq Age Sex Outcome Treatment
    1