BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    FS DISPOSABLE INTERFACE

    MDR report key: 16261012 · Received January 27, 2023

    Report

    Report Number
    3012236936-2023-00190
    Event Type
    Malfunction
    Date Received
    January 27, 2023
    Report Date
    July 28, 2023
    Manufacturer
    JOHNSON & JOHNSON SURGICAL VISION, INC.
    Product Code
    HNO
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE (1) INVESTIGATION WAS COMPLETED DURING THE PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    LOT NUMBERS OF THE DEVICES AND QUANTITY: 60328672 (X14), 60296764 (X12), 60333690 (X12), 60341112 (X11), 60357170 (X10), 60383020 (X9), 60379006 (X9), 60389491 (X9), 60298837 (X9), 60323225 (X9), 60317391 (X8), 60375374 (X8), 60396479 (X8), 60355767 (X8), UNKNOWN (X8), 60311912 (X6), 60376065 (X6), 60343419 (X6), 60320253 (X6), 60332109 (X5), 60348567 (X5), 60390926 (X5), 60403113 (X5), 60343189 (X5), 60394053 (X4), 60370558 (X4), 60336893 (X4), 60309863 (X4), 60358903 (X4), 60358902 (X3), 60303339 (X3), 60330262 (X3), 60371231 (X3), 60343420 (X3), 60383021 (X3), 60401425 (X3), 60388200 (X3), 60389250 (X3), 60377741 (X3), 60375573 (X3), 60347301 (X3), 60394054 (X2), 60405221 (X2), 60403114 (X2), 60377739 (X2), 60385030 (X2), 60347544 (X2), 60287678 (X1), 60264642 (X1), 60292889 (X1), 60141169 (X1), 60298836 (X1), 60297881 (X1), 60377740 (X1), 60311315 (X1), 60336894 (X1), 60319241 (X1), 60324362 (X1), 60271092 (X1), 60301370 (X1), 60338314 (X1), 60323882 (X1). ONE HUNDRED AND FIFTY NINE INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. FROM THOSE THE FOLLOWING WAS FOUND: TEN PRODUCTS WERE RETURNED INCOMPLETE, FOUR PRODUCTS WERE RETURNED BROKEN AND 1 WAS FOUND TO HAVE AN OPERATIONAL PROBLEM. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR¿S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR¿S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT¿S CORNEA AND THE SUCTION RING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: FIFTY (53) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. FOR 7 INVESTIGATIONS THE PRODUCT EVALUATION WAS NOT POSSIBLE BECAUSE THE PRODUCT WAS RECEIVED LOOSE INSIDE THE BOX AND INDIVIDUAL PRODUCT COMPONENTS COULD NOT BE ASSOCIATED WITH THEIR CORRESPONDING COMPLAINT EVENTS, LOT NUMBERS, OR COMPLAINT/INVESTIGATION FILES. FOR 4 INVESTIGATIONS THE DEVICE WAS RECEIVED INCOMPLETE, FOR 1 THE DEVICE WAS BROKEN. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 276 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401319 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT HNO JOHNSON & JOHNSON SURGICAL VISION, INC. 590106AN 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown