BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    23GA COMBINED VITRECTOMY PACK WITH VALVES AND AFI AND WIDE FIELD ILLUMINATOR

    MDR report key: 8659583 · Received May 31, 2019

    Report

    Report Number
    0001920664-2019-00100
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 2, 2019
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT AVAILABLE FOR EVALUATION, AS SUCH NO DEFINITIVE CONCLUSION CAN BE DRAWN AS TO THE SOURCE OF THE CUTTING PROBLEM. ONE OTHER COMPLAINT FROM THE SAME LOT, SG-2019-6150 / 880065 WAS IDENTIFIED FOR A SIMILAR REASON CODE. THE PRODUCT WAS RETURNED FOR EVALUATION, AND THE COMPLAINT CONFIRMED DUE TO A CLOG IN THE CUTTER. 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 DEEMED NECESSARY. THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    MANUFACTURING AND STERILIZATION RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. DEVICE NOT AVAILABLE AS IT WAS AN INFECTIOUS CASE; HOSPITAL HAD TO DISCARD. ADDITIONAL INVESTIGATION RESULTS ARE PENDING.

    Description of Event or Problem · 1

    A USER FACILITY IN (B)(6) REPORTED THAT DURING SURGERY A CUTTER WAS NOT CUTTING WELL AT CERTAIN ANGLES. ANOTHER PACK WAS OPENED FOR THE SURGEON. NO PATIENT IMPACT/INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452572 23GA COMBINED VITRECTOMY PACK WITH VALVES AND AFI AND WIDE FIELD ILLUMINATOR UNIT, PHACOFRAGMENTATION HQC BAUSCH + LOMB BL5523WVX W2388

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLARIS VISION ENHANCEMENT SYSTEM