BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTO-CAM MARYLAND DISS MONO 5

    MDR report key: 1380190 · Received May 5, 2009

    Report

    Report Number
    9680515-2009-00002
    Event Type
    Other
    Date Received
    May 5, 2009
    Date of Event
    March 15, 2009
    Report Date
    April 16, 2009
    Manufacturer
    TONTARRA MEDIZINTECHNIK GMBH
    Product Code
    HRR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER INITIALLY REPORTS, VIA A COPY OF THEIR MEDWATCH, THAT A MARYLAND DISSECTOR BROKE INTRA-ABDOMINALLY DURING A LAPAROSCOPIC SURGERY. THE SURGEON WAS UNABLE TO RETRIEVE A SMALL METAL PIECE APPROXIMATELY THE SIZE OF A STAPLE. THERE WAS NO PT INJURY REPORTED. THE LOSS PREVENTION SPECIALIST REPORTED TO ME THAT A NISSEN-FUNDOPLICATION WAS BEING PERFORMED ON A (B)(6) MALE PT WHEN THE REPORTED ISSUE TOOK PLACE. A PEDIATRIC ULTRASOUND OF THE GALLBLADDER WAS PERFORMED AND THEIR WAS NO DOCUMENTATION OF VISUALIZING THE METAL PIECE. SHE FURTHER STATED THAT THE "PORTION OF THE DEVICE THAT FAILED WAS AT THE HINGE ABOVE THE GRASPER. THERE WAS NO CONCERN ABOUT THE METAL PIECE IN REFERENCE TO FURTHER TESTS BECAUSE THE SIZE OF THE PIECE WAS CONGRUENT WITH STAPLES THAT ARE NORMALLY LEFT IN THE BODY, THEREFORE THEY DECIDED THERE WAS NO FURTHER NEED FOR INTERVENTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTO-CAM MARYLAND DISS MONO 5 NA HRR TONTARRA MEDIZINTECHNIK GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR