BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7

    MDR report key: 11657947 · Received April 13, 2021

    Report

    Report Number
    1723170-2021-00983
    Event Type
    Injury
    Date Received
    April 13, 2021
    Date of Event
    May 15, 2020
    Report Date
    April 13, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE UNIQUE IDENTIFIER WAS NOT KNOWN AT THE TIME OF REPORTING CONCOMITANT MEDICAL PRODUCTS: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_NAV_COMP, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. THE MANUFACTURE DATE WAS NOT KNOWN AT THE TIME OF REPORTING.

    Description of Event or Problem · 1

    MINCHEV, G., KRONREIF, G., PTACEK, W., KETTENBACH, J., MICKO, A., WURZER, A., MASCHKE, S., WOLFSBERGER, S. FRAMELESS STEREOTACTIC BRAIN BIOPSIES: COMPARISON OF MINIMALLY INVASIVE ROBOT-GUIDED AND MANUAL ARM-BASED TECHNIQUE. OPERATIVE NEUROSURGERY. 19 (292¿301) DOI: 10.1093/ONS/OPAA123 BACKGROUND: MOST BRAIN BIOPSIES ARE STILL PERFORMED WITH THE AID OF A NAVIGATION-GUIDED MECHANICAL ARM. DUE TO THE MANUAL TRAJECTORY ALIGNMENT WITHOUT RIGID SKULL CONTACT, FRAMELESS AIMING DEVICES ARE PRONE TO CONSIDERABLY LOWER ACCURACY. OBJECTIVE: TO COMPARE A NOVEL MINIMALLY INVASIVE ROBOT-GUIDED BIOPSY TECHNIQUE WITH RIGID SKULL FIXATION TO A STANDARD FRAMELESS MANUAL ARM BIOPSY PROCEDURE. METHODS: ACCURACY, PROCEDURAL DURATION, DIAGNOSTIC YIELD, COMPLICATION RATE, AND COSMETIC RESULT WERE RETROSPECTIVELY ASSESSED IN 40 CONSECUTIVE CASES OF FRAMELESS STEREOTACTIC BIOPSIES AND COMPARED BETWEEN A MINIMALLY INVASIVE ROBOTIC TECHNIQUE USING THE ISYS1 GUIDANCE DEVICE (ISYS MEDIZINTECHNIK GMBH) (ROBOT-GUIDED GROUP [ROB], N = 20) AND A MANUAL ARM-BASED TECHNIQUE (GROUP MAN, N = 20). RESULTS: APPLICATION OF THE ROBOTIC TECHNIQUE RESULTED IN SIGNIFICANTLY HIGHER ACCURACY AT ENTRY POINT (GROUP ROB MEDIAN 1.5 MM [0.4-3.2 MM] VS MANUAL ARM-BASED GROUP (MAN) 2.2 MM [0.2-5.2 MM], P = .019) AND AT TARGET POINT (GROUP ROB 1.5 MM [0.4-2.8 MM] VS GROUP MAN 2.8 MM [1.4-4.9 MM], P = .001), WITHOUT INCREASING INCISION TO SUTURE TIME (GROUP ROB 30.0 MIN [20-45 MIN VS GROUP MAN 32.5 MIN [RANGE 20-60 MIN], P = .09) AND SIGNIFICANTLY SHORTER SKIN INCISION LENGTH (GROUP ROB 16.3 MM [12.7-23.4 MM] VS GROUP MAN 24.2 MM [18.0-37.0 MM], P = .008). CONCLUSION :ACCORDING TO OUR DATA, THE PROPOSED TECHNIQUE OF MINIMALLY INVASIVE ROBOT GUIDED BRAIN BIOPSIES CAN IMPROVE ACCURACY WITHOUT INCREASING OPERATING TIME WHILE BEING EQUALLY SAFE AND EFFECTIVE COMPARED TO A STANDARD FRAMELESS ARM-BASED MANUAL BIOPSY TECHNIQUE. REPORTED EVENTS: 2 PATIENTS ONE FROM EACH GROUP HAD A HEMORRHAGE AT THE TARGET SITE POSTOPERATIVE CT SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555539 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other