BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILAP

    MDR report key: 15454311 · Received September 20, 2022

    Report

    Report Number
    15454311
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 26, 2022
    Report Date
    August 30, 2022
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    OCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN THE DOCTOR WAS HANDED TELEFLEX MEDICAL PGAC300 MINILAP MINIGRIP ALLIGATOR GRASPER, THE DOCTOR TOUCHED THE HANDLE AND THE PLASTIC PIECE FOR RATCHET SNAPPED OFF. IT WAS OPENED TO THE SCRUB AND HANDED DIRECTLY TO THE DOCTOR. (REF # PGAC300, LOT FML-00340).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636351 MINILAP ENDOSCOPIC TISSUE APPROXIMATION DEVICE OCW TELEFLEX INCORPORATED IPN002705 GML-00340

    Patients

    Seq Age Sex Outcome Treatment
    1 29930 DA Male