BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR CANNULA DANDY

    MDR report key: 8206775 · Received December 31, 2018

    Report

    Report Number
    9610612-2018-00611
    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. DATE OF MANUFACTURE IS 02/2018 (MONTH/YEAR) DAY OF MONTH IS UNKNOWN. 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). THE DEVICE RELATED TO THIS MEDWATCH REPORT WAS VISUALLY AND MICROSCOPICALLY INVESTIGATED. IT WAS DETERMINED THAT THIS DEVICE DISPLAYED VISIBLE DAMAGE, INCLUDING PERFORATIONS. LATEX EXAMINATION GLOVES WERE USED TO DETERMINE IF THE PERFORATION HAS A SHARP EDGE; THE GLOVE WAS 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. THE DAMAGE PRESENT ON THIS DEVICE MAY HAVE RESULTED FROM IMPROPER HANDLING, OR MAY HAVE BEEN CAUSED BY ANOTHER INSTRUMENT. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE FOLLOWING MUST BE OBSERVED: SAFE HANDLING AND PREPARATION: - PRIOR TO EACH USE, INSPECT THE PRODUCT FOR LOOSE, BENT, BROKEN, CRACKED, WORN OR FRACTURED COMPONENTS. - DO NOT USE THE PRODUCT IF IT IS DAMAGED OR DEFECTIVE. SET ASIDE THE PRODUCT IF IT IS DAMAGED. INSPECTION, MAINTENANCE AND CHECKS: - REPEAT CLEANING AND DISINFECTION OF PRODUCTS THAT STILL SHOW IMPURITIES OR CONTAMINATION - CHECK THAT THE PRODUCT FUNCTIONS CORRECTLY.

    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: 9610612-2018-00622; 9610612-2018-00623; 9610612-2018-00624; 9610612-2018-00625; 9610612-2018-00626.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045504 VENTRICULAR CANNULA DANDY CANNULA HCD AESCULAP AG FF124R

    Patients

    Seq Age Sex Outcome Treatment
    1