BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014

    MDR report key: 4911116 · Received July 13, 2015

    Report

    Report Number
    0002936485-2015-00630
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 16, 2015
    Report Date
    June 19, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    FAS
    PMA / PMN Number
    K040390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUTTING LOOP WAS VISUALLY INSPECTED FOR DAMAGES, AND THE DISTAL CUTTING TIP HAS BROKEN OFF. THE TIP WAS NOT RECEIVED WITH THE PRODUCT. UNABLE TO FUNCTION TEST THE CUTTING LOOP DUE TO THE BROKEN DISTAL TIP. THE PROBABLE ROOT CAUSES COULD BE HANDLING DURING SETUP, OR DAMAGED DURING SHIPPING. THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE FROM THE CUTTING LOOP ELECTRODE BROKE OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WIRE FROM THE CUTTING LOOP ELECTRODE BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452092 22 FR, 30 DEGREE CUTTING LOOP ELECTRODE, .014 ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL FAS STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1