BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OEC 3D

    MDR report key: 16548135 · Received March 15, 2023

    Report

    Report Number
    1720753-2023-00001
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 14, 2023
    Report Date
    April 25, 2023
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    OBW
    PMA / PMN Number
    K203346
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED AND THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE TECHNOLOGIST HAD SELECTED THE WRONG PATIENT POSITION (SUPINE INSTEAD OF PRONE) PRIOR TO THE OEC 3D TAKING THE IMAGE. FOR THIS CASE, THE OPERATOR THOUGHT THE IMAGE WOULD DISPLAY A POSTERIOR-ANTERIOR PROJECTION WHEN IT WAS TRULY DISPLAYING AN ANTERIOR-POSTERIOR PROJECTION. THE SYSTEM DOES ALLOW FOR A USER TO ROTATE OR FLIP THE IMAGE TO GET THE VIEW THEY WOULD LIKE AFTER THE IMAGE IS TAKEN. THE SYSTEM LABELS THE IMAGES BASED ON THE PATIENT POSITION SELECTED. THE IMAGE WAS MISDIAGNOSED RESULTING IN THE WRONG PEDICLE SCREW BEING REMOVED. THERE WERE NO PROBLEMS IDENTIFIED WITH THE OEC 3D SYSTEM. RECOMMENDATIONS WERE MADE TO THE USER TO ALWAYS TO SELECT THE CORRECT PATIENT POSITION AND TO USE THE ROTATE AND FLIP FUNCTIONALITY TO GET THE IMAGE VIEW DESIRED. NO FURTHER ACTIONS ARE NEEDED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. UNIQUE IDENTIFIER: (B)(4). LEGAL MANUFACTURER: SURGERY SLC - 384 N WRIGHT BROTHERS DR USA SALT LAKE CITY, UT 84116.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN THEY WERE PERFORMING A BILATERAL SI JOINT FUSION AND S1-L1 FUSION PROCEDURE USING THEIR OEC 3D MOBILE C-ARM SYSTEM ON A PATIENT, THE SURGEON DETERMINED THAT THERE WAS A PEDICLE SCREW THAT REQUIRED REMOVAL. HE THEN REFERENCED THE 3D IMAGE AND REMOVED THE PEDICLE SCREW. LATER, DURING A POST-OP CT SCAN, THE SURGEON REALIZED THAT HE HAD REMOVED THE INCORRECT PEDICLE SCREW. THE PATIENT THEN HAD TO BE BROUGHT BACK TO THE OR TO HAVE THE CORRECT PEDICLE SCREW REMOVED AND REPLACE THE INCORRECT SCREW THAT WAS PREVIOUSLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115324 OEC 3D FLUOROSCOPIC X-RAY OBW GE OEC MEDICAL SYSTEMS, INC OEC 3D FBMHDX00160

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention