BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX

    MDR report key: 6100992 · Received November 14, 2016

    Report

    Report Number
    2027111-2016-00818
    Event Type
    Malfunction
    Date Received
    November 14, 2016
    Date of Event
    October 14, 2016
    Report Date
    January 11, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GCJ
    UDI-DI
    00607915125714
    PMA / PMN Number
    K041795
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO FDA PRODUCT CODES AND PMA/510(K) NUMBERS ARE NOTED AS THE EVENT PRODUCT IS A KIT CONTAINING TWO DEVICES WITH DIFFERENT PRODUCT CODES, (B)(4) AND 510(K) NUMBERS, K093296 AND K041795. THE EVENT PRODUCT IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE WITH 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA. THERE IS NO REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE ALEXIS® LAPAROSCOPIC SYSTEM, KII FIOS TROCAR AND A SEAL FRAGMENT WERE RETURNED FOR EVALUATION. ENGINEERING DISASSEMBLED THE SEAL AND NOTED THAT THE SEPTUM WAS FOUND TO BE TORN AND MISSING A PORTION. THE FRAGMENT RETURNED ALONG WITH THE EVENT UNIT MATCHED THE MISSING PORTION OF THE SEPTUM. 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 THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED - UNKNOWN: - "THE CONSULTANT DURING THE CASE "NOTICED A BLACK FRAGMENT IN THE ABDOMEN. THE SURGEON WAS USING AN ENDORACTOR THROUGH THE PORT AT THE TIME. THE PORT WAS REMOVED AND ON INSPECTION IT LOOKED LIKE A PART OF THE SEAL WAS MISSING." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM SALES REPRESENTATIVE ON (B)(6) 2016: "AN ENDORACTOR WHICH WAS USED TO PACK THE SMALL BOWEL AWAY FROM THE OPERATING FIELD WAS INSERTED THROUGH THE PORT. IT WAS AFTER THIS THAT THE SURGEON NOTICED A SMALL BLACK FRAGMENT IN THE PATIENT. THIS WAS THEN REMOVED FROM THE PATIENT, THE TROCAR WAS REPLACED AND PROCEDURE COMPLETED." PATIENT STATUS: "NO PATIENT INJURY OR ILLNESS OCCURRED ASSOCIATED WITH THE COMPLAINT EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750834 C8701, S ALEXIS LAP SYS W/ KII FIOS 5/BX KGW, GCJ GCJ APPLIED MEDICAL RESOURCES C8701 1270846 00607915125714

    Patients

    Seq Age Sex Outcome Treatment
    1