BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOH ULTRAMICRO INJECTION NEEDLE

    MDR report key: 3881739 · Received May 23, 2014

    Report

    Report Number
    9610617-2014-00022
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    HET
    PMA / PMN Number
    K950962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT WAS EVALUATED AND WE CONFIRMED THE DISTAL END OF THE INJECTION NEEDLE IS BROKEN OFF AND IS MISSING. CUSTOMER REPORTED THAT THE NEEDLE NEVER PENETRATED THE CYST. WE BELIEVE IT IS POSSIBLE THE CYST HAD CALCIFIED, CAUSING THE NEEDLE TO BREAK WHEN THE DOCTOR ATTEMPTED TO PENETRATE THE CYST. THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY 4 MONTHS. WE SHOW NO DEFECT TREND; THIS IS THE ONLY REPORT WE HAVE FOR THIS PRODUCT/ISSUE.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A LAPAROSCOPIC CYSTECTOMY, WHEN THE DOCTOR ATTEMPTED TO GO INTO THE CYST WITH THE NEEDLE, THE NEEDLE BENT AND BROKE OFF INTO THE PATIENT'S ABDOMEN WITHOUT PENETRATING THE CYST. THE BROKEN PIECE WAS IMMEDIATELY RETRIEVED AND ANOTHER INSTRUMENT WAS USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308670 KOH ULTRAMICRO INJECTION NEEDLE INJECTION NEEDLE HET KARL STORZ GMBH & CO. KG 26176NA XX01

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention