BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH BLUNT CHERRY DISSECTOR

    MDR report key: 212932 · Received March 3, 1999

    Report

    Report Number
    1527736-1999-01218
    Event Type
    Malfunction
    Date Received
    March 3, 1999
    Report Date
    February 17, 1999
    Manufacturer
    CARWILD CORPORATION
    Product Code
    KNS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    INCOMPLETE INFO FROM AFFILIATE. THE EVENT IS WRITTEN IN GERMAN. AWAITING RESPONSE FROM AFFILIATE. 3/2/99 MESSAGE FROM AFFILIATE. IT WAS REPORTED THAT (12) DEVICES WERE USED DURING A LAPAROSCOPIC HERNIA REPAIR. IT WAS REPORTED BY THE AFFILIATE THAT THE BCD10 INSTRUMENT TIPS FELL OFF AND INTO THE PT. ALL (12) WERE INVOLVED IN THIS CASE. ALL TIPS WERE RETRIEVED FROM THE PT. ALL DEVICES WILL NOT BE RETURNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other