BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR CANNULA DANDY

    MDR report key: 8206732 · Received December 31, 2018

    Report

    Report Number
    9610612-2018-00626
    Event Type
    Malfunction
    Date Received
    December 31, 2018
    Date of Event
    December 6, 2018
    Report Date
    December 31, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    HCD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2014018 . INVESTIGATION RESULTS: INITIAL REPORTER INDICATED SIX DEVICES OF THE SAME LOT NUMBER EXHIBITED THE REPORTED SHARP EDGE AT THE DRILL HOLE/PERFORATION. SIX DEVICES WERE RETURNED FOR INVESTIGATION. THREE WERE IN AN OPEN AND USED CONDITION, THE OTHER THREE WERE RETURNED UNUSED IN THE ORIGINAL PACKAGE. THE THREE OPENED DEVICES ALL HAVE DIFFERENT MANUFACTURE DATES, WHICH INDICATES THEY ARE FROM DIFFERENT LOTS AND NONE OF THEM SHARE THE SAME MANUFACTURE DATE / LOT NUMBER OF THE PRODUCTS RETURNED IN PACKAGE (ALL THREE PACKAGED ARE FROM SAME LOT NUMBER). A DEVICE OF THE SAME LOT, RETURNED BY THE CUSTOMER WAS INVESTIGATED RELATED TO THIS MEDWATCH REPORT. IT WAS DETERMINED THAT THE INVESTIGATED DEVICE DISPLAYED NO VISIBLE DAMAGE. LATEX EXAMINATION GLOVES WERE USED TO TEST TO DETERMINE IF SHARP EDGE EXISTED, THE GLOVES WERE NOT DAMAGED. THE LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED, THEREFORE, REVIEW OF DEVICE HISTORY RECORDS FOR THIS LOT NUMBER COULD NOT BE COMPLETED. REVIEW OF DEVICE QUALITY AND MANUFACTURING RECORDS WERE CHECKED FOR THE REPORTED LOT NUMBER (4509784027) AND WERE FOUND TO BE ACCORDING TO SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS WERE REPORTED FOR THIS BATCH NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SURGEON HAS 6 VENTRICULAR CANNULAS THAT HAVE A SHARP EDGE AT THE DRILL HOLE / PERFORATION THAT COULD LEAD TO BRAIN TISSUE INJURY WHEN THE CANNULA IS RETRACTED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THESE DEVICES. ALL ARE REPORTED AS THE SAME LOT/BATCH NUMBER. ALL MEDWATCH REPORTS ASSOCIATED WITH THIS REPORT INCLUDE: 9610612-2018-00611; 9610612-2018-00622; 9610612-2018-00623 ; 9610612-2018-00624 ; 9610612-2018-00625; - UNOPENED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045028 VENTRICULAR CANNULA DANDY CANNULA HCD AESCULAP AG FF124R 4509784027

    Patients

    Seq Age Sex Outcome Treatment
    1