BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX

    MDR report key: 5743194 · Received June 22, 2016

    Report

    Report Number
    2027111-2016-00469
    Event Type
    Malfunction
    Date Received
    June 22, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 21, 2016
    Manufacturer
    AMR
    Product Code
    GCJ
    UDI-DI
    00607915116453
    PMA / PMN Number
    K060629
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED FROM THE CUSTOMER AND PROVIDED. INVESTIGATION SUMMARY: THE EVENT UNIT WAS RETURNED FOR EVALUATION. UPON INSPECTION, ENGINEERING NOTED NO VISIBLE DAMAGE TO THE EXTERIOR OF THE DEVICE OR TO THE DUCKBILL. ENGINEERING FOUND THE SEPTUM TO BE TORN AND MISSING A PORTION. ENGINEERING NOTED THAT A TEAR IN THE SEPTUM CAN ALLOW FOR THE SHIELD TO BECOME DISLODGED MORE EASILY, WHICH COULD HAVE BEEN A CONTRIBUTING FACTOR IN THE CUSTOMER EXPERIENCE REPORTED. THE MISSING PORTION OF THE SEPTUM AND THE SHIELD WERE NOT RETURNED FOR EVALUATION. ALL SEALS ARE THOROUGHLY INSPECTED AND TESTED FOR LEAKAGE DURING THE MANUFACTURING PROCESS. THE DAMAGE TO THE SEPTUM APPEARS TO HAVE BEEN CAUSED BY AN INSTRUMENT. THERE IS ALWAYS A POTENTIAL TO TEAR OR DISLODGE THE INTERNAL SEAL COMPONENTS WITH MULTIPLE PASSES OF INSTRUMENTS, ESPECIALLY WITH SHARP OR ANGULAR DEVICES. THE INSTRUCTIONS FOR USE (IFU) WARNS THAT EXTRA CARE SHOULD BE USED WHEN INSERTING ANGULAR AND ASYMMETRICAL INSTRUMENTS. ALL INSTRUMENTS SHOULD BE CENTERED AXIALLY WHEN INSERTED THROUGH THE SEAL TO PREVENT TEARING. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS AND WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED UNKNOWN - "THE SURGEON PASSED A RETRIEVAL POUCH THROUGH THE PORT. PART OF THE PORT (TRANSPARENT INSTRUMENT SEAL/GUARD) DETACHED FROM THE PORT ENTERING THE PATIENTS ABDOMINAL CAVITY. THIS WAS SEEN BY THE SCRUB PRACTITIONER AND THE SURGEON RETRIEVED IT. THE PART WHICH DETACHED IS HOUSED WITHIN THE SEAL SO IT WOULD NOT HAVE BEEN NOTICED DURING THE INSTRUMENT CHECK." PATIENT STATUS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397271 C0R47, 12X100 KII BALLOON BLUNT TIP 6/BX GCJ GCJ AMR C0R47 1262833 00607915116453

    Patients

    Seq Age Sex Outcome Treatment
    1