BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH BLUNT CHERRY DISSECTOR

    MDR report key: 126647 · Received October 16, 1997

    Report

    Report Number
    1527736-1997-02663
    Event Type
    Injury
    Date Received
    October 16, 1997
    Date of Event
    September 17, 1997
    Report Date
    September 18, 1997
    Manufacturer
    CARWILD CORPORATION
    Product Code
    KNS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED THE TIP OF THE BCD10 CAME OFF AND FELL INTO THE PT. THE SURGEON COULD NOT LOCATE THE TIP SO THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE. 9/19/97 IT WAS REPORTED THE SURGEON WAS APPROXIMATELY HALFWAY THROUGH THE PROCEDURE AND WAS DISSECTING STRUCTURES IN THE INGUINAL AREA WHEN THE TIP OF THE BCD10 CAME COMPLETELY OFF THE SHAFT OF THE DEVICE. AFTER EXPLORING 10 MINUTES LAPAROSCOPICALLY FOR THE TIP THE SURGEON CONVERTED TO AN OPEN PROCEDURE AND RETRIEVED THE TIP. THE SURGEON THEN COMPLETED THE PROCEDURE. 10/8/97 IT WAS REPORTED THE SALES REP IS SENDING BACK TWO BCD10 DEVICES NOT USED DURING THE PROCEDURE, BUT WERE TESTED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other