BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20 GA HIGH SPEED VITRECTOMY CUTTER

    MDR report key: 8379816 · Received February 28, 2019

    Report

    Report Number
    0001920664-2019-00043
    Event Type
    Malfunction
    Date Received
    February 28, 2019
    Date of Event
    January 31, 2019
    Report Date
    January 31, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WE HAVE CONCLUDED THAT THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE COMPLAINT DATABASE REVEALED 2 OTHER COMPLAINTS FOR SIMILAR REASON CODE HAVE BEEN SUBMITTED AGAINST LOT NO. W1575. SEE REPORTS 0001920664-2019-00031 AND 0001920664-2019-00053. CAPA 610815 WAS CLOSED ON 06 JULY 2018 BUT WAS STILL OPEN WHEN LOT NO. W1575 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, INCLUDING BL5612. THE FIRST LOT OF BL5612 THAT WAS BUILT WITH THE VITRECTOMY TUBESET ENHANCEMENT WAS LOT NO. W2064 IN JUNE 2018. ANY BL5612 PRODUCT WITH LOT NO. W2064 OR HIGHER WILL INCLUDE THE VITRECTOMY TUBESET ENHANCEMENT. THE LOT HISTORY, TREND ANALYSIS, RISK ANALYSIS AND/OR DIRECTIONS FOR USE REVIEW WERE CONSIDERED ACCEPTABLE, WITH THE PRODUCT PERFORMING WITHIN ANTICIPATED RATES. NO FURTHER INVESTIGATION OR CORRECTIVE ACTION IS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE USER FACILITY IN THE (B)(6) REPORTED THAT THE CUTTER WOULD NOT CUT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. NO PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172129 20 GA HIGH SPEED VITRECTOMY CUTTER UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5612 W1575

    Patients

    Seq Age Sex Outcome Treatment
    1