BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 2223283 · Received August 25, 2011

    Report

    Report Number
    1056128-2011-00087
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    GEI
    PMA / PMN Number
    K012700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR AN EVALUATION SO A ROOT CAUSE COULD NOT BE DETERMINED. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE STATES: "DAMAGE TO THE INSTRUMENT OR THE INSULATION CAN LEAD TO SHOCK AND BURN INJURIES. ALWAYS INSPECT THE INSTRUMENT CAREFULLY BEFORE USE FOR OVERALL INSTRUMENT INTEGRITY AND FOR INTEGRITY OF THE INSULATION AND GROUNDING." "TO AVOID COMPROMISING THE INSULATION, DO NOT BEND OR STRAIN INSTRUMENT SHAFT." THE DEVICE HISTORY RECORD FOR THE RETURNED DEVICE INDICATES THAT THE COMPLAINT DEVICE PASSED ALL APPLICABLE INSPECTIONS AND TESTS PRIOR TO RELEASE. THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION ON THE DISTAL TIP OF THE LAPAROSCOPIC SCISSORS WAS UNRAVELING. NO PATIENT INJURY WAS REPORTED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A GEI GEI STRYKER SUSTAINABILITY SOLUTIONS 5DCS 1619507

    Patients

    Seq Age Sex Outcome Treatment
    1