BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 8685110 · Received June 10, 2019

    Report

    Report Number
    3005075853-2019-19597
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 20, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001706
    PMA / PMN Number
    K081146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ADDITIONAL INFORMATION RECEIVED: THE CORRECT LOT NUMBER OF EC60A IS R9446R. THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE LOT NUMBER AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE: BATCH # UNK. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE RADICAL RESECTION OF PULMONARY CARCINOMA SURGERY, WHEN SEVERING LOBE OF LUNG, AFTER FIRED, NOTED SOME STAPLES MALFORMED WITH IRREGULAR SHAPE AND THE CUT EDGE OF THE VESSEL WAS BLEEDING, USED SUTURE TO OVERSEW. THE PATIENT IS STABLE AND IN THE HOSPITAL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475164 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. R9446R 10705036001706

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR