BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITE STAR HIGH SPEED VIT CUTTER

    MDR report key: 7767455 · Received August 9, 2018

    Report

    Report Number
    3006695864-2018-01652
    Event Type
    Malfunction
    Date Received
    August 9, 2018
    Date of Event
    July 13, 2018
    Report Date
    November 2, 2020
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC
    Product Code
    MLZ
    UDI-DI
    05050474534117
    PMA / PMN Number
    K081681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE AVAILABLE FOR EVALUATION? YES. RETURNED TO MANUFACTURER ON: 08/10/2018. DEVICE RETURNED TO MANUFACTURER? YES. THE DISPOSABLE VITRECTOMY CUTTER WAS RETURNED WITHIN ITS ORIGINAL PACKAGING CONFIRMING THE REPORTED LOT NUMBER OF 60087423. A VISUAL INSPECTION OF THE RETURNED DEVICE SHOWED NEITHER THE INNER OR OUTER PACKAGE WAS OPENED. FAILURE MODE OF MISLABELED SAMPLE WAS CONFIRMED AS THERE IS A 20GA VIT CUTTER LABELED AS 25GA. THE REPORTED MISLABELING ISSUE WAS CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.

    Additional Manufacturer Narrative · 0

    ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    A SURGERY CENTER REPORTED MISLABELING ON TWO DISPOSABLE VITRECTOMY CUTTERS. A BRIEF DESCRIPTION FROM THE SURGERY CENTER INDICATED THEY ORDERED SIZE 25-GAUGE DISPOSABLE VITRECTOMY CUTTERS BUT UPON OPENING THE PACKAGE, THE ACTUAL VITRECTOMY CUTTER HAD SIZE 20-GAUGE ENGRAVED ON THE DEVICE. NO INDICATION OF PATIENT CONTACT. THIS IS 2 OF 2 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608757 WHITE STAR HIGH SPEED VIT CUTTER DISPOSABLE VITRECTOMY CUTTER MLZ JOHNSON & JOHNSON SURGICAL VISION, INC NGP0025 60087423 05050474534117

    Patients

    Seq Age Sex Outcome Treatment
    1