BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR TRIGGER-FLEX PROBE

    MDR report key: 2190177 · Received May 27, 2008

    Report

    Report Number
    3007024186-2008-00001
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 27, 2008
    Manufacturer
    ELLIQUENCE, LLC
    Product Code
    GEI
    PMA / PMN Number
    K003126
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRIGGER-FLEX INTENDED USE IS TO ABLATE DISC TISSUE. DURING INTENDED USE, ACCESS TO THE DISC IS GAINED WITH A TREPHINE AND THEN THE TRIGGER-FLEX IS INSERTED THROUGH AN ENDOSCOPE CHANNEL SO THAT THE ACTIVATED TRIGGER-FLEX TIP IS IN CONTACT WITH THE TISSUE TO BE ABLATED. IN THIS SURGERY, THE TRIGGER-FLEX BIPOLAR PROBE WAS USED TO MECHANICALLY "ENTER THE DISC" AS OPPOSED TO USING A TREPHINE. IT HAS BEEN DETERMINED THAT THIS ACTION CAUSED THE TIP TO BREAK. WE HAVE REVIEWED THE PROCEDURE VIDEO WHICH CONFIRMED THE MISUSE AND RESULTANT FAILURE. CONCLUSION AND ANALYSIS: THE UNITS WERE TESTED IN THE CHICKEN MEAT MODEL UNDER MUCH MORE SEVERE CONDITIONS THAN THEY WOULD BE SUBJECTED TO DURING NORMAL CLINICAL USE DUE TO THE EXTENDED TIMES (E.G. GREATER THAN 2 MINUTES). SOME SAMPLES WERE ALSO SUBJECTED TO THE HIGHER POWER THAN WOULD NORMALLY BE EXPERIENCED DURING NORMAL CLINICAL USE. EVEN UNDER THE EXTREME CONDITIONS THAT THE SAMPLES WERE SUBJECTED TO, THE BREAKING OFF OF AN ELECTRODE TIP WAS NEVER OBSERVED. FURTHERMORE, WHEN THE ELECTRODES WERE SUBJECTED TO THE PULL TEST, THEY ALL FAILED AT GREATER THAN 23 LBS. THIS IS SIGNIFICANTLY HIGHER THAN WOULD BE EXPERIENCED DURING NORMAL CLINICAL USE. IT IS ALSO NOTEWORTHY THAT THE USED SAMPLES DID NOT BREAK AT SIGNIFICANTLY LOWER FORCES THAN THE UNUSED SAMPLES, INDICATING THAT USE IN EXTREME CONDITIONS DOES NOT SIGNIFICANTLY ADVERSELY AFFECT THE STRENGTH OF THE ELECTRODES.

    Description of Event or Problem · 1

    THE TRIGGER-FLEX BIPOLAR PROBE WAS USED TO MECHANICALLY "ENTER THE DISC" DURING AN ENDOSCOPIC SPINE PROCEDURE INSTEAD OF USING A TREPHINE. THIS ACTION CAUSED THE TIP OF THE PROBE TO BREAK. WHEN THE INSTRUMENT WAS WITHDRAWN, AND IT WAS REALIZED THAT THE TIP HAD BROKEN, THE C-ARM WAS USED TO LOCATE THE TIP FRAGMENT. THE FRAGMENT WAS THEN REMOVED VIA AN ENDOSCOPIC GRASPING FORCEPS FROM WITHIN THE PATIENT. THE PATIENT SUFFERED NO ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR TRIGGER-FLEX PROBE TRIGGER-FLEX BIPOLAR SYSTEM GEI ELLIQUENCE, LLC 080101294

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SYSTEM| RICHARD WOLF MEDICAL INSTRUMENT'S ENDOSCOPIC| ELLMAN SURGI-MAX