BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3MM DOUBLE ACTION ATRAUMATIC GRASPER, 20CM

    MDR report key: 2061203 · Received April 11, 2011

    Report

    Report Number
    2936485-2011-00234
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 30, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CASE, THE INSTRUMENT BROKE INSIDE THE PT. IT WAS FURTHER REPORTED THAT ALL THE BROKEN PIECES WERE RETRIEVED AND THE PT WAS NOT HARMED. FURTHER, THE CASE WAS EXTENDED OVER AN HOUR DURING THE RETRIEVAL PROCESS WHICH REQUIRED ADD'L ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3MM DOUBLE ACTION ATRAUMATIC GRASPER, 20CM GRASPER HRX STRYKER ENDOSCOPY SAN JOSE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other