BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH BLUNT CHERRY DISSECTOR

    MDR report key: 232948 · Received July 21, 1999

    Report

    Report Number
    1527736-1999-03958
    Event Type
    Malfunction
    Date Received
    July 21, 1999
    Report Date
    June 23, 1999
    Manufacturer
    CARWILD CORPORATION
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (4) DEVICES WERE USED DURING A GASTRIC BYPASS. IT WAS REPORTED BY THE AFFILIATE THAT THE BCD10 TIPS FELL OFF AND INTO THE PATIENT(THEY WERE RETRIEVED). ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH BLUNT CHERRY DISSECTOR INSTRUMENTS - ENDOSCOPIC KNS CARWILD CORPORATION NA M4DP2E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other