BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISP.UNIV-SEALING UNIT F/10/12MM TROCARS

    MDR report key: 6176675 · Received December 15, 2016

    Report

    Report Number
    2916714-2016-01044
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 1, 2017
    Manufacturer
    AESCULAP AG
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE THAT IS REGISTERED WITHIN THE U.S. (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: JAPAN. IT WAS REPORTED THAT DURING SURGERY, THE SURGEON NOTICED THAT THERE WAS AN AIR LEAKAGE WITH THE DEVICE. HE CHECKED THE DEVICE AND DISCOVERED THAT THE SEALING UNIT WAS BROKEN. THE FRAGMENT WAS FOUND IN THE PATIENT'S BODY AND REMOVED. THE FRAGMENT FOUND MATCHED THE MISSING PART OF THE SEALING UNIT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A KEYENCE VHX-5000 DIGITAL MICROSCOPE AND A PANASONIC DMC TZ8 DIGITAL CAMERA. WE MADE A VISUAL INSPECTION OF THE SEALING UNITS. FIRST WE INVESTIGATED THE FIRST SEALING UNIT. HERE WE FOUND UNKNOWN IMPURITIES AND VISIBLE DAMAGE. ADDITIONALLY WE MADE VISUAL INSPECTION OF THE FIRST SEALING UNIT WITHOUT THE LOCKING RING EK002241. HERE WE FOUND THAT THE BLINDING PROTECTOR EK00252 AND UNIVERSAL CONVERTER EK002250 IS NOT CENTERED. FURTHERMORE, WE MADE A VISUAL INSPECTION OF THE BLINDING PROTECTORAND UNIVERSAL CONVERTER. HERE WE FOUND UNKNOWN IMPURITIES. NEXT WE INVESTIGATED THE SECOND SEALING UNIT. HERE WE FOUND UNKNOWN IMPURITES. ADDITIONALLY WE MADE A VISUAL INSPECTION OF THE SECOND SEALING UNIT WITHOUT THE LOCKING RING EK002241. HERE WE FOUND UNKNOWN IMPURITIES. FURTHERMORE, WE MADE A VISUAL INSPECTION OF THE BLINDING PROTECTOR EK00252 AND UNIVERSAL CONVERTER EK002250. HERE WE FOUND UNKNOWN IMPURITIES. NEXT WE INVESTIGATED THE THIRD SEALING UNIT. HERE WE FOUND UNKNOWN IMPURITES. ADDITIONALLY WE MADE A VISUAL INSPECTION OF THE SECOND SEALING UNIT WITHOUT THE LOCKING RING EK002241. HERE WE FOUND UNKNOWN IMPURITIES. FURTHERMORE, WE MADE A VISUAL INSPECTION OF THE BLINDING PROTECTOR EK00252 AND UNIVERSAL CONVERTER EK002250. HERE WE FOUND UNKNOWN IMPURITIES. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE LOT NUMBERS AND FOUND TO BE ACCORDING TO SPECIFICATION, VALID AT THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. WE ASSUME THAT THE VISIBLE DAMAGE WAS CAUSED DURING THE INSERTION OF THE INSTRUMENT. THERE IS THE POSSIBILITY THAT THE NOT CENTERED COMPONENTS WERE CAUSED BY AN OVERLOAD SITUATION. NO CAPA IS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827915 DISP.UNIV-SEALING UNIT F/10/12MM TROCARS ENDOSCOPY GCJ AESCULAP AG EK002SU 52189937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other