BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23 GA HIGH SPEED VITRECTOMY CUTTER

    MDR report key: 8662808 · Received June 3, 2019

    Report

    Report Number
    0001920664-2019-00090
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    March 5, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    UDI-DI
    20757770057911
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION COMPLETED. ONE OPENED BL5623 POUCH FROM LOT W1629 WAS RETURNED. THE EXPIRATION DATE ON THE LABEL IS 2019-09-03. THE TIP PROTECTOR WAS NOT RETURNED. 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 IN THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED, AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER HAD GOOD CLEAN CUTS THROUGHOUT THE VARIOUS CUT RATES, ASPIRATED AND PERFORMED AS INTENDED. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO CORRECTIVE ACTION REQUIRED. REFER TO CAPA 610815. CAPA 610815 WAS CLOSED ON 06 JULY 2018 BUT WAS STILL OPEN WHEN LOT W1629 WAS MANUFACTURED. PER CAPA 610815 AND QCR (B)(4) 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, INCLUDING BL5623. THE FIRST LOT OF BL5623 THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT #W2027 IN JUN-2018. ANY BL5623 PRODUCT WITH LOT NO. W2027 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT.

    Additional Manufacturer Narrative · 1

    THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. FURTHER INVESTIGATION UNDERWAY.

    Description of Event or Problem · 1

    THE USER FACILITY IN (B)(6) REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING THE VITREOUS; HOWEVER, ASPIRATION CONTINUED. THERE WAS NO IMPACT OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455316 23 GA HIGH SPEED VITRECTOMY CUTTER UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5623 W1629 20757770057911

    Patients

    Seq Age Sex Outcome Treatment
    1