BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSTERIOR VITRECTOMY PACK

    MDR report key: 3963570 · Received May 30, 2014

    Report

    Report Number
    1920664-2014-00086
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN REQUESTED; HOWEVER, IT HAS NOT YET ARRIVED. STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A USER FACILITY IN (B)(6) STATING: "USING 23 GAUGE VITRECTOMY CUTTER TO PERFORM THE CORE VITRECTOMY WITH A FIXED CUT PROGRAM, THEY MENTIONED SEEING THE CUTTER STOPPING AT HIGH VACUUM (PROGRAM MAXING AT 500 MMHG). THE SYSTEM STILL WAS ACTIVE AND THEY DID NOT NOTICE ANY CHANGES IN THE VITRECTOR SOUND. THEY OBSERVED TRACTION AND HAD TO REDUCE THE VACUUM TO RE-ACTIVATE THE CUTTER. THERE WAS NO INJURY TO THE PATIENT AND THE SURGERY WAS PERFORMED ACCORDING TO PLAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319971 POSTERIOR VITRECTOMY PACK HQC BAUSCH & LOMB BL5523W V1693

    Patients

    Seq Age Sex Outcome Treatment
    1