BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERKELEY SAFE-TOUCH 10/PKG TISSUE TRAPS

    MDR report key: 24989398 · Received April 24, 2026

    Report

    Report Number
    3011050570-2026-00469
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Report Date
    April 24, 2026
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HHK
    PMA / PMN Number
    K030935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BERKELEY SAFE TOUCH TISSUE TRAP EXHIBITED A GREEN, STICKY RESIDUE AND BLACK MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489229 BERKELEY SAFE-TOUCH 10/PKG TISSUE TRAPS BERKELEY SAFE-TOUCH 10/PKG TISSUE TRAPS HHK GYRUS ACMI, INC. 003853-902 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown