BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 5926829 · Received September 2, 2016

    Report

    Report Number
    1723170-2016-02121
    Event Type
    Malfunction
    Date Received
    September 2, 2016
    Date of Event
    August 1, 2016
    Report Date
    September 2, 2016
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHTS WERE NOT PROVIDED BY THE AUTHORS. DATE OF EVENT IS UNKNOWN; DATE OF PUBLICATION IS USED INSTEAD. NASSER, RANI, DONIEL DRAZIN, JONATHAN NAKHLA, LUTFI AL-KHOUJA, EARL BRIEN, ELI M. BARON, TERRENCE T. KIM, J. PATRICK JOHNSON, AND REZA YASSARI. "RESECTION OF SPINAL COLUMN TUMORS UTILIZING IMAGE-GUIDED NAVIGATION: A MULTICENTER ANALYSIS." NEUROSURGICAL FOCUS 41.2 (2016): 1-13. WEB. SCATTER DUE TO PREVIOUSLY PLACED HARDWARE IS A KNOWN RISK WHEN PERFORMING SURGERY WITH A RADIOLOGICAL DEVICE. OTHER REPORTED EVENTS WERE REMEDIED WITH PROPER SETUP TECHNIQUE. NO PARTS WERE REPLACED OR RETURNED.

    Description of Event or Problem · 1

    ATTACHED ARTICLE, RESECTION OF SPINAL COLUMN TUMORS UTILIZING IMAGE-GUIDED NAVIGATION: A MULTICENTER ANALYSIS BY NASSIR AND DRAZIN ET AL. STATES CIRCUMSTANCES WHICH CAN AFFECT NAVIGATION ACCURACY WITH THE STEALTHSTATION AND O-ARM SYSTEMS.: "THE SCATTER ARTIFACT FROM PRIOR HARDWARE MAY COMPROMISE THE NAVIGATIONAL ACCURACY OF THE O-ARM. OTHER CIRCUMSTANCES, SUCH AS INTRAOPERATIVE VERTEBROPLASTY, MAY POSE NAVIGATIONAL CHALLENGES. STEREOTACTIC GUIDANCE CERTAINLY AUGMENTS OUR SURGICAL ABILITY, BUT IS NOT A SUBSTITUTE FOR ANATOMICAL KNOWLEDGE AND SURGICAL TECHNIQUE. AS HELPFUL AS THIS TECHNOLOGY HAS BECOME IN THE OPERATING ROOM, IT MUST NOT BE RELIED UPON AS A SUBSTITUTE FOR KNOWLEDGE OF AND ATTENTION TO ANATOMY." "IN ADDITION, THE BENEFIT OF THE MAYFIELD REFERENCE FRAME POSITIONED AWAY FROM THE DIRECT SURGICAL FIELD TRANSLATED INTO LESS RISK OF ACCIDENTAL COLLISION AND FEWER LINE-OF SIGHT ISSUES. COMPARED WITH PLACEMENT OF CLAMPS ON THORACIC SPINOUS PROCESSES, WHICH TEND TO BE LESS ROBUST, WE FOUND THE PEDICLE SCREW REFERENCE FRAME TO BE HIGHLY RIGID AND STABLE. FOR LUMBAR AND SACRAL TUMOR SURGERY, THE CHOICE OF A PERCUTANEOUS REFERENCE PIN IN THE ILIUM VERSUS A SPINOUS PROCESS REFERENCE CLAMP VERSUS A PEDICLE SCREW BASED FRAME IS DEBATABLE. IN OUR EARLIER EXPERIENCES, WE FOUND THAT THE PERCUTANEOUS PIN PLACED IN THE POSTERIOR SUPERIOR ILIAC SPINE OFTEN INTERFERED WITH THE SURGEON'S AND/OR ASSISTANT'S OPERATIVE FIELD AND OFTEN CAUSED LINE-OF-SIGHT ISSUES. AS A RESULT, WE PREFERRED THE REFERENCE CLAMP PLACED ON A PROXIMAL OR DISTAL LUMBAR SPINOUS PROCESS, DIRECTED AWAY FROM THE SURGICAL AREA. ADDITIONALLY, WE WOULD ELECT TO USE THE PEDICLE SCREW BASED REFERENCE FRAME IF PEDICLE INSTRUMENTATION WAS PRESENT IN THE OPERATIVE FIELD. THE STEALTH- STATION WORKSTATION (MEDTRONIC, INC.) AND LED (LIGHTEMITTING DIODE) DETECTOR CAMERA WERE PLACED AT EITHER THE HEAD OF THE BED OR THE FOOT OF THE OPERATING TABLE, DEPENDING ON THE DIRECTION OF THE REFERENCE FRAME. CAREFUL ATTENTION TO NAVIGATED REFERENCE FRAME SELECTION AND STEALTH- STATION PLACEMENT ARE 2 EXAMPLES OF CRITICAL PREOPERATIVE ISSUES THAT A SURGEON MUST CONSIDER IN ORDER TO MAXIMIZE NAVIGATED WORKFLOW EFFICIENCY IN TUMOR SURGERY. INSERTION OF INSTRUMENTATION UNDER NAVIGATION GUIDANCE IN SPINAL SURGERY REQUIRES A STRICT ADHERENCE TO BASIC RULES. IN OUR TECHNIQUE, WE ALWAYS EMPHASIZE MINIMIZING "MANIPULATION" OR PULLING OR PUSHING OF THE SURROUNDING SOFT TISSUE AND BONY SPINE. DURING TAP CANNULATION AND SCREW INSERTION, SIGNIFICANT FORCES MAY BE APPLIED TO THE VERTEBRAL BODY, WHICH CAN MOVE IT FROM ITS ORIGINAL IMAGED POSITION. THIS CAN LEAD TO SIGNIFICANT INACCURACY AND MALPLACEMENT OF INSTRUMENTATION. CURRENT NAVIGATION TECHNOLOGY IS UNABLE TO ACCOUNT FOR SHIFTS IN VERTEBRAL BODY POSITION AND DYNAMIC CHANGES IN THE SPINAL BONY ANATOMY. AS A RESULT, WE RECOMMEND THAT EXTREME CARE BE TAKEN TO MINIMIZE ANY FORCE THAT MIGHT DISPLACE OR ALTER THE ALIGNMENT OF THE OPERATED SPINE. MINIMIZING SOFT TISSUE RETRACTION AND MANIPULATION OF THE BONY SPINE MINIMIZES VARIANCE IN NAVIGATION TRAJECTORY AND ULTIMATELY TRANSLATES INTO MORE ACCURATE PEDICLE SCREWS. THE USE OF THE IMAGE-GUIDED NAVIGATION SYSTEM CAN BE REGARDED AS AN ADDITIONAL OPERATIVE STEP THAT INCREASES THE ANESTHESIA TIME AND HENCE INCREASES THE RISK FOR THE PATIENT WITH CANCER. HOWEVER, THERE ARE MANY STUDIES WHICH ACTUALLY FIND THE NAVIGATION SYSTEM SHORTENS THE LENGTH OF THE PROCEDURE WHEN THE USER IS EXPERIENCED WITH THE SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577416 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR O-ARM O2 IMAGING SYSTEM