BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EB010, VOYANT 5MM FUSION 37CM, 6/BX

    MDR report key: 5802860 · Received July 19, 2016

    Report

    Report Number
    2027111-2016-00525
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 20, 2016
    Report Date
    February 16, 2017
    Manufacturer
    AMR
    Product Code
    GEI
    UDI-DI
    00607915117856
    PMA / PMN Number
    K141288
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE DEVICE KEY WAS RETURNED FOR EVALUATION. THE DEVICE KEY IS THE PORTION OF THE DEVICE THAT CONNECTS THE DEVICE TO THE GENERATOR; IT HOUSES A MICROCHIP WHICH STORES INFORMATION ON ALL OF THE ACTIVATIONS DURING THAT PROCEDURE. ENGINEERING ANALYZED THE DEVICE ACTIVATION LOGS AND FOUND THAT THERE WERE TWO "REACTIVATE SWITCH RELEASED" ALARMS WHICH OCCUR WHEN THE FUSE BUTTON IS RELEASED PRIOR TO SEAL COMPLETION. THIS COULD BE RELATED TO THE COMPLAINANT'S EXPERIENCE; HOWEVER, IN THE ABSENCE OF THE COMPLETE EVENT DEVICE, IT IS DIFFICULT TO CONFIRM THE RESULTS OF THE ACTIVATION LOGS AND DETERMINE THE ROOT CAUSE OF THE EVENT. ALTHOUGH THE ROOT CAUSES OF INSUFFICIENT HEMOSTASIS AND STICKING ON TISSUE COULD NOT BE CONFIRMED, APPLIED MEDICAL IS CURRENTLY IMPLEMENTING CORRECTIVE ACTIONS WITHIN A CORRECTIVE AND PREVENTATIVE ACTION REPORT TO MITIGATE THESE TYPES OF EVENTS. IN ACCORDANCE TO 21 CFR 803.56, IF ADDITIONAL INFORMATION IS OBTAINED WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAP GASTRIC SLEEVE- "ACTIVATION #(B)(4), SURGEON HAD A BLEEDER ON THE OMENTUM SIDE AT THE GREATER CURVATURE OF THE STOMACH. ARTERY WAS APPROXIMATELY 1MM. CONTINUED TO OOZE. TOOK (B)(4) ADDITIONAL ACTIVATIONS TO GET THE OOZING/BLEEDING TO STOP. ACTIVATION #(B)(4) BLEEDER ON THE OMENTUM SIDE AT THE GREATER CURVATURE OF THE STOMACH. SURGEON ACTIVATED (B)(4) ADDITIONAL TIMES TO CONTROL OOZING/BLEEDING FROM ACTIVATION (B)(4) AND (B)(4). (NOTICED (B)(4) WAS STILL BLEEDING SO HE WENT BACK TO REACTIVATE.) " SURGEON HAD SOME STICKING ISSUES AROUND ACTIVATION (B)(4). JAWS HAD BEEN CLEANED AT ACTIVATION #(B)(4). NO STICKING BEFORE #(B)(4). CLEANED WITH WET GAUZE. INTERMITTENT STICKING AFTER THAT. ABLE TO REMOVE DEVICE FROM TISSUE WITHOUT ANY BLEEDING." TYPE OF INTERVENTION: "ABLE TO FINISH WITH THAT DEVICE." PATIENT STATUS - "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456836 EB010, VOYANT 5MM FUSION 37CM, 6/BX GEI GEI AMR EB010 1265230 00607915117856

    Patients

    Seq Age Sex Outcome Treatment
    1 Other