BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINOP INVENT BIPOLAR 40DG D2.7MM L310MM

    MDR report key: 6140021 · Received December 1, 2016

    Report

    Report Number
    2916714-2016-01008
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    October 31, 2016
    Report Date
    July 18, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    GWG
    PMA / PMN Number
    K983365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE INVESTIGATION WAS PERFORMED USING A KEYENCE VHX-5000 DIGITAL MICROSCOPE. THE GOLDEN SCISSOR BLADE OF THE COMBINATION INSTRUMENT IS NO LONGER WORKING, DUE TO THE BLADE BEING BENT, AND THUS THE CONNECTION TO THE GUIDING RAIL FAILED. THE DEVIATION OF THE BLADE WAS MOST LIKELY CAUSED BY A LEVERAGE WHEN THE BLADE WAS OPEN. FURTHERMORE, THE MOVEABLE PART OF THE FORCEPS JAW IS UNEVEN, WHICH IS ALSO AN INDICATOR OF A LEVERAGE EFFECT DURING APPLICATION. ACCORDING TO THE IFU, EXCESSIVE FORCES MUST BE AVOIDED. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILBLE LOT NUMBER AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION, THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. NO CAPA IS NECESSARY.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: USA. IT IS REPORTED THAT THE SURGEON WAS PERFORMING A PROCEDURE USING AN INVENT BIPOLAR SYSTEM. THE SURGEON REPORTED HE HAD DIFFICULTY PULLING THE ANGLE BIPOLAR OUT OF THE TROCAR. HE FINALLY WAS ABLE TO REMOVE IT BY TURNING IT SIDEWAYS. ABOUT FIVE MINUTES LATER HE NOTICED WHAT APPEARED TO BE A LARGE PIECE OF BLACK PLASTIC FLOATING AROUND THE THIRD VENTRICLE. THE SURGEON ALSO REPORTED THAT WHEN HE LOOKED DOWN THE TROCAR, HE NOTICED NOTHING WAS BLOCKING THE WORKING CHANNEL. IT TOOK THE SURGEON TEN MINUTES TO RETRIEVE THE PIECE OF PLASTIC. THERE WAS NO REPORTED HARM TO THE PATIENT. THERE WAS A TEN-MINUTE DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788578 MINOP INVENT BIPOLAR 40DG D2.7MM L310MM NEUROSURGICAL SYSTEMS GWG AESCULAP AG GK344R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other