BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHTO SUCTION/IRRIGATION TUBE SET (6BX)

    MDR report key: 4860869 · Received June 22, 2015

    Report

    Report Number
    0002936485-2015-00523
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    May 12, 2015
    Report Date
    May 29, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LJH
    PMA / PMN Number
    K042457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE MODE OF "FOREIGN MATERIAL" WAS CONFIRMED ON THE UNIT RETURNED FOR EVALUATION. AS PER RISK DOCUMENTS MOST PROBABLE ROOT CAUSES FOR THE FOLLOWING FAILURE MODE ARE: 1. MANUFACTURING/ASSEMBLY ERROR. 2. USER ERROR IN NOT PROPERLY INSPECTING UNIT PRIOR TO USE. BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE IS DEEMED TO BE MANUFACTURING/ASSEMBLY ERROR. 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 HAIR WAS FOUND IN THE PACKAGE DURING UNPACKING THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HAIR WAS FOUND IN THE PACKAGE DURING UNPACKING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403372 AHTO SUCTION/IRRIGATION TUBE SET (6BX) SYSTEM, IRRIGATION, UROLOGICAL LJH STRYKER ENDOSCOPY-SAN JOSE 14303FG2

    Patients

    Seq Age Sex Outcome Treatment
    1