BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PKG. ASSY. SUCTION IRRIGATOR 2

    MDR report key: 23884396 · Received December 23, 2025

    Report

    Report Number
    0002936485-2025-01019
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 3, 2025
    Report Date
    March 31, 2026
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    GCJ
    UDI-DI
    37613327061391
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INVESTIGATION WAS CLOSED BASED ON THE DEVICE NOT RECEIVED, THEREFORE THE REPORTED FAILURE MODE WAS NOT CONFIRMED. IN THE EVENT THAT THE DEVICE IS RECEIVED, THE COMPLAINT WILL BE REOPENED AND THE INVESTIGATION WILL BE UPDATED WITH NEW RESULTS. ALLEGED FAILURE: BLUE FLECK ON THE INSIDE OF THE PACKAGING. PROBABLE ROOT CAUSE: 1. INCORRECT OR INADEQUATE PACKAGING, 2. SEVERE SHIPPING CONDITIONS, 3. USER ERROR. THE REPORTED FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE UNIT WAS OBSERVED TO HAVE A BLUE FLECK ON THE INSIDE OF THE PACKAGING, AND THE OTHER UNIT HAD A BLUE SMEAR ON THE PART ITSELF AS WELL AS A FLECK OF SOMETHING ON THE RED KNOB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE UNIT WAS OBSERVED TO HAVE A BLUE FLECK ON THE INSIDE OF THE PACKAGING, AND THE OTHER UNIT HAD A BLUE SMEAR ON THE PART ITSELF, AS WELL AS A FLECK OF SOMETHING ON THE RED KNOB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802235 PKG. ASSY. SUCTION IRRIGATOR 2 LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ STRYKER ENDOSCOPY-SAN JOSE 25219FG2 37613327061391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown