BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EB240, VOYANT OPEN FUSION, 6/BX

    MDR report key: 16123629 · Received January 9, 2023

    Report

    Report Number
    2027111-2023-00310
    Event Type
    Injury
    Date Received
    January 9, 2023
    Date of Event
    December 8, 2022
    Report Date
    March 13, 2023
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    GEI
    UDI-DI
    00607915138455
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WILL NOT BE RETURNING TO APPLIED MEDICAL FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, APPLIED MEDICAL IS UNABLE TO DETERMINE IF THE EVENT UNIT EXHIBITED ANY NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE IF THE REPORTED EVENT WAS CAUSED BY A MANUFACTURING NON-CONFORMANCE OR CIRCUMSTANTIAL FACTORS AT THE TIME OF USE. APPLIED MEDICAL HAS REVIEWED THE DETAILS SURROUNDING THE EVENT AND IS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: PROSTATECTOMY. EVENT DESCRIPTION: DURING A PROSTATECTOMY, TO ACHIEVE HEMOSTASIS DISSECTION BETWEEN THE PROSTATE AND THE PLEXUS OF SANTORINI, THE SURGEON USED THE VOYANT. THIS ONE COAGULATED BUT DID NOT LOOSEN THE JAWS ANYMORE. CURRENT CONDITION OF THE PATIENT: THE PROSTATE WAS INJURED, TORN ON THE ANTERIOR SURFACE. ACTIONS TAKEN IN THE HEALTH CARE FACILITY TO MANAGE THE PATIENT: IMMEDIATELY CHANGED THE INSTRUMENT AND CHECK HEMOSTASIS AND SURROUNDING ORGANS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 2JAN23: INDICATION FOR THE SURGERY WAS PROSTATECTOMY FOR ADENOCARCINOMA IT WAS A FULL PROSTATECTOMY + LYMPH NODES. THE MANIFESTATION OF THE INJURY LEAD TO EXTENDED OPERATING TIME, NO ADDITIONAL DIAGNOSTICS OR MEDICAL/MEDICINAL TREATMENT, NO ADMISSION TO ICU OR EXTENDED HOSPITALIZATION. DIFFICULT TO EXPLAIN ADDITIONAL SURGICAL TREATMENT, BUT THE ANASTOMOSIS FOR THE URETER WAS PROCEED DIFFERENTLY AND MAY OCCUR LEAKS. NOTHING NOTIFY FOR THE MOMENT ABOUT UPDATED PATIENT STATUS. THE DEVICE WAS REMOVED BY CUTTING AROUND THE JAW WITH A SCALPEL. THERE WAS TISSUE BLEEDING AS A RESULT FROM DEVICE REMOVAL. THE BLEEDING WAS CORRECTED WITH A MONOPOLAR AND BIPOLAR. TYPE OF INTERVENTION: IMMEDIATELY CHANGED THE INSTRUMENT AND CHECK HEMOSTASIS AND SURROUNDING ORGANS. PATIENT STATUS: THE PROSTATE WAS INJURED, TORN ON THE ANTERIOR SURFACE.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: PROSTATECTOMY EVENT DESCRIPTION: LORS D'UNE PROSTATECTOMIE, POUR RÉALISER L'HÉMOSTASE DISSECTION ENTRE LA PROSTATE ET LE PLEXUS DE SANTORINI, LE CHIRURGIEN A UTILISÉ LE VOYANT. CELUI-CI A COAGULÉ MAIS N'A PLUS DESSERRÉ LES MORS. ÉTAT ACTUEL DU PATIENT : LA PROSTATE A ÉTÉ LÉSÉE, DÉCHIRÉE SUR LA SURFACE ANTÉRIEURE. ACTIONS ENTREPRISES DANS L¿ÉTABLISSEMENT DE SOINS POUR LA PRISE EN CHARGE DU PATIENT : CHANGEMENT IMMÉDIAT DE L'INSTRUMENT ET VÉRIFICATION DE L'HÉMOSTASE ET DES ORGANES AUTOUR. TRANSLATION: DURING A PROSTATECTOMY, TO ACHIEVE HEMOSTASIS DISSECTION BETWEEN THE PROSTATE AND THE PLEXUS OF SANTORINI, THE SURGEON USED THE VOYANT. THIS ONE COAGULATED BUT DID NOT LOOSEN THE JAWS ANYMORE. CURRENT CONDITION OF THE PATIENT: THE PROSTATE WAS INJURED, TORN ON THE ANTERIOR SURFACE. ACTIONS TAKEN IN THE HEALTH CARE FACILITY TO MANAGE THE PATIENT: IMMEDIATELY CHANGED THE INSTRUMENT AND CHECK HEMOSTASIS AND SURROUNDING ORGANS. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 2JAN23: INDICATION FOR THE SURGERY WAS PROSTATECTOMY FOR ADENOCARCINOMA IT WAS A FULL PROSTATECTOMY + LYMPH NODES THE MANIFESTATION OF THE INJURY LEAD TO EXTENDED OPERATING TIME, NO ADDITIONAL DIAGNOSTICS OR MEDICAL/MEDICINAL TREATMENT, NO ADMISSION TO ICU OR EXTENDED HOSPITALIZATION. DIFFICULT TO EXPLAIN ADDITIONAL SURGICAL TREATMENT, BUT THE ANASTOMOSIS FOR THE URETER WAS PROCEED DIFFERENTLY AND MAY OCCUR LEAKS. NOTHING NOTIFY FOR THE MOMENT ABOUT UPDATED PATIENT STATUS. THE DEVICE WAS REMOVED BY CUTTING AROUND THE JAW WITH A SCALPEL. THERE WAS TISSUE BLEEDING AS A RESULT FROM DEVICE REMOVAL. THE BLEEDING WAS CORRECTED WITH A MONOPOLAR AND BIPOLAR. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL 12JAN23: THERE WAS NO DAMAGE TO THE URETER, THE URETER WAS CUT PROPERLY FOR THE ANASTOMOSIS. THE SURGEON HAD TO CREATE A DIFFERENT TYPE OF ANASTOMOSIS THAN HE HAD ORIGINALLY PLANNED, HE HAS ADAPT WITH ANOTHER TISSUE. THIS NEW ANASTOMOSIS MAY CREATE LEAKS, BECAUSE USUALLY HE USE THE PART THAT WAS BLOCKED INTO THE JAWS. THE SURGEON HAD TO USE A DIFFERENT TECHNIQUE, HE HAD TO IMPROVISE WITH THE SURROUNDING TISSUES. TYPE OF INTERVENTION: IMMEDIATELY CHANGED THE INSTRUMENT AND CHECK HEMOSTASIS AND SURROUNDING ORGANS. PATIENT STATUS: THE PROSTATE WAS INJURED, TORN ON THE ANTERIOR SURFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511969 EB240, VOYANT OPEN FUSION, 6/BX ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI APPLIED MEDICAL RESOURCES EB240 1455774 00607915138455

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention EA020 GENERATOR