BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH BLUNT CHERRY DISSECTOR

    MDR report key: 207222 · Received January 18, 1999

    Report

    Report Number
    1527736-1999-00339
    Event Type
    Malfunction
    Date Received
    January 18, 1999
    Date of Event
    December 7, 1998
    Report Date
    December 7, 1998
    Manufacturer
    CARWILD CORPORATION
    Product Code
    KNS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THREE DEVICES WERE USED DURING A LAPAROSCOPIC NISSEN FUNDOPLICATION. IT WAS REPORTED BY THE AFFILIATE THAT WHEN DISSECTING WITH THE BCD10 INSTRUMENTS (THREE), THE COTTON WAS LOOSE AND FELL OFF INTO THE PT. THE SURGEON WASN'T COMPLETELY SURE THAT ALL OF THE COTTON WAS FOUND AND RETRIEVED. NO SHARP INSTRUMENT WAS USED AT THE SAME TIME AS THE CHERRY DISSECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH BLUNT CHERRY DISSECTOR INSTRUMENTS-ENDOSCOPIC KNS CARWILD CORPORATION NA L4C65D

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other