BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FS DISPOSABLE INTERFACE

    MDR report key: 11988028 · Received June 11, 2021

    Report

    Report Number
    3006695864-2021-07783
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 14, 2021
    Report Date
    August 6, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    GEX
    UDI-DI
    15050474534688
    PMA / PMN Number
    K060372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D9: DEVICE AVAILABLE FOR EVALUATION: YES , RETURNED TO MANUFACTURER ON 2 JUN, 2021. SECTION H3: DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: VISUAL INSPECTION WAS PERFORMED, AND NO OBVIOUS DAMAGE/DEFECT WAS OBSERVED. SUCTION TEST WAS PERFORMED, AND ALL RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT CANNOT BE CONFIRMED. MANUFACTURING RECORD REVIEW: PER MANUFACTURING RECORDS REVIEW REPORT, NO RELATED DEVIATION, NCMR, NC OR CAPA WAS INITIATED DURING THE MANUFACTURING PROCESS OF THE REPORTED LOT#. ALL DEVICES MEET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS AT THE TIME OF PRODUCT RELEASE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: THE AWARE DATE REPORTED IN THE INITIAL FILING IS (B)(6) 2021, HOWEVER AFTER FURTHER REVIEW THE CORRECT AWARE DATE WAS FOUND TO BE (B)(6) 2021. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH, WEIGHT, ETHNICITY: UNKNOWN/NOT PROVIDED. EMAIL ADDRESS: UNKNOWN/ NOT PROVIDED. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR PI HAD SUCTION ISSUES. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878909 FS DISPOSABLE INTERFACE POWERED LASER SURGICAL INSTRUMENT GEX AMO MANUFACTURING USA, LLC 590106AN 60290827 15050474534688

    Patients

    Seq Age Sex Outcome Treatment
    1