BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY

    MDR report key: 6361351 · Received February 15, 2017

    Report

    Report Number
    6361351
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    February 2, 2017
    Report Date
    February 10, 2017
    Manufacturer
    KARL STORZ ENDOSCOPY
    Product Code
    FFL
    UDI-DI
    04048551051672
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING THE SIALOENDOSCOPY PROCEDURE MULTIPLE STORZ STONE EXTRACTOR BASKETS WERE USED TO ATTEMPT TO EXTRACT A STONE THAT WAS LODGED IN A SALIVARY GLAND DUCT. THE BASKETS (REF #S 11575L, 11575K, 11582M) WERE ALL BROKEN AT SOME POINT DURING THE PROCEDURE WHETHER THEY WERE OPENED AROUND THE STONE OR JUST FROM SIMPLY BEING OPENED AND CLOSED ACCORDING TO THE PHYSICIAN WHO WAS PERFORMING THE PROCEDURE. DURING ONE OF THE ATTEMPTS TO EXTRACT A STONE BASKET WHICH WAS OPENED AROUND THE STONE BROKE OFF FROM THE REST OF THE DEVICE AND WAS LEFT AROUND THE STONE AND LODGED IN PLACE MAKING IT IRRETRIEVABLE. MANY ATTEMPTS WERE MADE TO RETRIEVE THE STONE AND THE BASKET AROUND THE STONE, BUT WERE UNSUCCESSFUL. SOME OF THE BASKETS WERE LEFT RETAINED INSIDE THE SALIVARY GLAND DUCT. OVERALL, 8 BASKETS WERE BROKEN IN SOME FASHION DURING THE COURSE OF THIS PROCEDURE. THERE WERE 8 STONE EXTRACTOR BASKETS USED AND ALL 8 FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117400 KARL STORZ ENDOSCOPY STONE EXTRACTOR, 0.6MM FFL KARL STORZ ENDOSCOPY 115757K 5237040A 04048551051672

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention