BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX)

    MDR report key: 4910661 · Received July 13, 2015

    Report

    Report Number
    0002936485-2015-00628
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 16, 2015
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    LJH
    PMA / PMN Number
    K042457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PARTICLE/DEBRIS CONDITION WAS NOT CONFIRMED SINCE THE UNIT WAS NOT RECEIVED. AS PER RISK DOCUMENT LIKELY ROOT CAUSES ARE: 1. MANUFACTURING/ASSEMBLY ERROR; 2. INCORRECT OR INADEQUATE PACKAGING; 3. SEVERE SHIPPING CONDITIONS. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE RESIDUE WAS FOUND ON THE PROBE OF THE PRODUCT. THE WHITE RESIDUE WAS NOTICED AT THE BEGINNING OF THE CASE WHEN THEY WERE OPENING THE PACKAGING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHITE RESIDUE WAS FOUND ON THE PROBE OF THE PRODUCT. THE WHITE RESIDUE WAS NOTICED AT THE BEGINNING OF THE CASE WHEN THEY WERE OPENING THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452624 AHTO SUCTION/IRRIGATION TUBE SET WITH DISPOSABLE TIP (6BX) SYSTEM, IRRIGATION, UROLOGICAL LJH STRYKER ENDOSCOPY-SAN JOSE 14302FG2

    Patients

    Seq Age Sex Outcome Treatment
    1