BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24FR STANDARD FLOW RESECTOSCOPE SHEATH

    MDR report key: 3041592 · Received April 8, 2013

    Report

    Report Number
    0002936485-2013-00128
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HIH
    PMA / PMN Number
    K040390
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS PHYSICALLY RETURNED AND REPAIRED BEFORE BEING FULLY EVALUATED BY A COMPLAINTS TECHNICIAN. HOWEVER, BASED ON THE REPAIR DIAGNOSTICS, THE UNIT WAS CONFIRMED TO HAVE A DAMAGED SHEATH AND THEREFORE CONFIRMING THE REPORTED FAILURE MODE. PAST COMPLAINTS INVOLVING THIS PRODUCT AND THIS REPORTED FAILURE HAVE BEEN PRIMARILY CAUSED BY: DROPPING/BANGING OF THE DEVICE AGAINST A HARD SURFACE AND/OR IMPROPER STERILIZATION METHODS. IN SUM, THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE SHEATH BURNED OFF AND FELL INTO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE TIP OF THE SHEATH BURNED OFF AND FELL INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143401 24FR STANDARD FLOW RESECTOSCOPE SHEATH HYSTEROSCOPE (AND ACCESSORIES) HIH STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1