BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 GA POSTERIOR PROCEDURAL PACK WITH WF

    MDR report key: 7713452 · Received July 24, 2018

    Report

    Report Number
    0001920664-2018-00089
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Report Date
    June 29, 2018
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    20757770058086
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE OPENED VITRECTOMY CUTTER PACK. THE TIP PROTECTOR WAS NOT RETURNED. THE EXTENSION HANDLE WAS PLACED OVER THE NEEDLE SHAFT IN AN ATTEMPT TO PROTECT THE NEEDLE. THE NEEDLE WAS NOT BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE TUBING. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE ON THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED AND NO DAMAGE WAS FOUND. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER DID NOT CUT. THE INNER NEEDLE CLOSED AND REMAINS CLOSED PREVENTING CUTTING AND ASPIRATION. THE PRODUCT EVALUATION CONFIRMED THE FAILURE MODE. CAPA 610815 WAS CLOSED ON 06 JULY 2018 BUT WAS STILL OPEN WHEN LOT V9567 WAS MANUFACTURED. PER CAPA 610815 AND QCR 332663 THE VITRECTOMY TUBESET USED ON THE STELLARIS PC PACKS AND STANDALONE POUCHED VITRECTOMY CUTTERS WAS REPLACED WITH A NEW VITRECTOMY TUBESET. THE NEW VITRECTOMY TUBESET PROVIDES A GREATER OPERATING RANGE BETWEEN THE PRESSURE REQUIRED TO CLOSE THE VITRECTOMY CUTTER INNER NEEDLE AND THE PRESSURE REQUIRED TO OPEN THE VITRECTOMY CUTTER INNER NEEDLE. THE VITRECTOMY TUBESET ENHANCEMENT WAS IMPLEMENTED ON THE IMPACTED PC PACKS AND POUCHED ACCESSORIES. THE FIRST LOT OF BL5223W THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT #W2087 IN JUN 2018. ANY BL5223W PRODUCT WITH LOT NO. W2087 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT.

    Additional Manufacturer Narrative · 1

    PRODUCT HAS BEEN REQUESTED FOR EVALUATION HOWEVER IT HAS NOT BEEN RECEIVED.STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND NO EXCEPTIONS WERE FOUND.

    Description of Event or Problem · 1

    DURING A CATARACT PROCEDURE THE VITRECTOMY CUTTER STOPPED CUTTING. A NEW PACK WAS OPENED TO CONTINUE THE SURGERY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555352 23 GA POSTERIOR PROCEDURAL PACK WITH WF UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5223W V9567 20757770058086

    Patients

    Seq Age Sex Outcome Treatment
    1