BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MID LABS

    MDR report key: 2584901 · Received May 11, 2012

    Report

    Report Number
    2935428-2012-00002
    Event Type
    Malfunction
    Date Received
    May 11, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 11, 2012
    Manufacturer
    MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
    Product Code
    MLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: REPORT: VITREOUS CUTTER DID NOT CUT. ANALYSIS: VITREOUS CUTTER WAS RETURNED BENT. VITREOUS CUTTER TESTED AND INSPECTED AND DID NOT MEET CUT TEST SPECIFICATION DUE TO THE VITREOUS CUTTER BEING BENT.

    Description of Event or Problem · 1

    DR TRIED TWO CUTTERS OF 2540CE BOTH IN THE SAME LOT AND THEY WOULD NOT CUT. THEY DIDN'T DO ANYTHING. THEY DID HAVE PT CONTACT, BUT NO INJURY. CUTTERS WERE TESTED PRIOR TO SURGERY AND WORKED. WHEN SURGERY STARTED THE CUTTER SOUNDED LIKE IT WAS WORKING BUT WAS NOT CUTTING. ASPIRATION CONTINUED. THEY TRIED THE 20 GAUGE THEY HAD ON HAND AND IT WORKED. THEY BORROWED A 25 GAUGE FROM THE HOSP WITH A DIFFERENT LOT NUMBER AND THEY ALSO WORKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MID LABS VITREOUS CUTTER MLZ MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC. 11070508

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK