BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODULAR TABLE

    MDR report key: 5410296 · Received February 4, 2016

    Report

    Report Number
    2921578-2016-00005
    Event Type
    Injury
    Date Received
    February 4, 2016
    Date of Event
    March 20, 2015
    Report Date
    April 6, 2016
    Manufacturer
    MIZUHO ORTHOPEDIC SYSTEMS, INC.
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE WHICH DEVICE WAS INVOLVED IN THIS INCIDENT. MIZUHO OSI MANUFACTURES SEVERAL DEVICES THAT COULD BE DESCRIBED AS A WEIRD LOOKING TABLE WITH SKI BOOTS ON THE BOTTOM. MIZUHO AMERICA, ANOTHER MEDICAL DEVICE MANUFACTURER NAMED IN THE REPORT, DOES NOT LIST ANY SUCH DEVICES. IF THE REPORT IS CORRECT IN IDENTIFYING THE EQUIPMENT AS A MIZUHO OSI MODULAR TABLE, THE SETUP COULD INCLUDE EITHER AN ORTHOPEDIC TRAUMA TOP OR A RADIOLUCENT IMAGING TOP WITH A HIP ARTHROSCOPY KIT. OTHER POSSIBLE MIZUHO OSI DEVICES INCLUDE THE HANASSXT SURGICAL TABLE EXTENSION, THE PROFX PELVIC RECONSTRUCTION ORTHOPEDIC FRACTURE TABLE, OR THE HANA ORTHOPEDIC SURGERY TABLE. UNABLE TO DETERMINE WHICH USER FACILITY WAS INVOLVED IN THIS INCIDENT, NOR EXACTLY WHAT IT WAS THAT HAPPENED. THE CAUSE OF THE EVENT IS MOST LIKELY A DEFICIENCY IN THE HOSPITAL'S PATIENT TRANSFER PROCEDURE, OR INADEQUATE TRAINING ON THAT PROCEDURE.

    Description of Event or Problem · 1

    I WAS SCHEDULED FOR A OUTPATIENT SCOPE FOR MY LEFT HIP AT HOSP, (B)(6). I WAS TAKEN INTO THE OPERATION THAT AFTERNOON. AS I WAS WHEELED IN THE OPERATING ROOM, I NOTICED THIS WEIRD LOOKING TABLE THAT LOOKED LIKE THE BOTTOM HAS TWO SKI BOOTS ATTACHED. I WOKE UP TO THE DOCTORS ASKING ME BASIC QUESTIONS, MY NAME, WHERE WAS I AND IF I HAD PAIN. I SAID MY HEAD AND LOWER BACK HAVE PAIN. THEN I HEARD THEM SAY TAKE HER TO CAT SCAN. I REMEMBER GOING INTO THE CAT SCAN AND THEN PASSED OUT. I CAME INTO RECOVERY WHERE MY HUSBAND TOLD ME THAT I SLID OFF THE OPERATING TABLE. I WAS STILL SATIATED AND THE BREATHING TUBE STILL IN MY MOUTH WHEN I FELL TO THE FLOOR. I FOUND OUT THE NEXT DAY THAT AFTER THE SURGERY THE DOCTOR HAD REMOVED THE PIN AND I WAS BEING HELD ON THE TABLE BY THE BOOTS AND 3 PIECES OF TAPE AROUND MY CHEST. I WAS TOLD THAT WHEN THE NURSE REMOVED THE BOOTS AND ANTHOLOGIST TURNED AWAY TO GET A BED AND AT THE SAME TIME THE NURSE TOOK MY FOOT OUT OF THE BOOTS AND THE TABLE MOVED CAUSING ME TO SLIDE DOWN, BREAKING THE TABLE AND FALLING HEAD FIRST TO THE FLOOR. I WAS HOSPITALIZED FOR 4 DAYS. HAD A CONCUSSION, HEADACHE AND BLURRED VISION, WHICH ARE STILL AFFECTING ME TODAY. I AM NOT SURE OF ALL THE DETAILS ON THE TABLE LIKE MODEL NUMBER, ETC. I WAS ABLE TO GET THAT INFO FROM THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68665 MODULAR TABLE SURGERY TABLE FQO MIZUHO ORTHOPEDIC SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization