BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 18791617 · Received February 27, 2024

    Report

    Report Number
    3005075853-2024-01668
    Event Type
    Injury
    Date Received
    February 27, 2024
    Date of Event
    January 1, 2024
    Report Date
    April 22, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/16/2024. ADDITIONAL INFORMATION RECEIVED: CUÁLES FUERON LAS INDICACIONES PARA LA INTERVENCIÓN QUIRÚRGICA? CÁNCER GÁSTRICO. ¿QUÉ PROCEDIMIENTO QUIRÚRGICO SE REALIZÓ? LAPAROSCOPIA MÁS GASTRECTOMIA TOTAL ¿RECIBIÓ EL PACIENTE QUIMIOTERAPIA O RADIOTERAPIA PREOPERATORIA? SI. ¿HUBO ALGÚN PROBLEMA CON EL DISPOSITIVO EN EL PROCEDIMIENTO QUIRÚRGICO INICIAL? NO. ¿QUÉ PROFESIONAL SANITARIO DISPARÓ EL DISPOSITIVO Y CUÁL ES SU EXPERIENCIA CON EL MISMO? DR (B)(6). ¿EN QUÉ PUNTO DE LA ESCALA DE AJUSTE DEL ESPACIO VERDE SE ENCONTRABA EL INDICADOR ANTES DEL DISPARO (B BAJO, B MEDIO O B ALTO)? ALTO. ¿ESPERÓ EL PROFESIONAL SANITARIO 15 SEGUNDOS DESPUÉS DE CERRAR EL DISPOSITIVO Y VOLVIÓ A APRETARLO ANTES DE DISPARAR? SI. ¿HUBO ALGÚN PROBLEMA CON EL USO/DISPARO DEL DISPOSITIVO? NO. ¿QUÉ CONFIRMACIÓN SE RECIBIÓ DE QUE EL DISPOSITIVO COMPLETÓ LA SECUENCIA DE DISPARO? SI ¿ERA VISIBLE LA MARCA DE VERIFICACIÓN VERDE AL FINAL DE LA COCCIÓN? SI. ¿CUÁNTAS VUELTAS EN SENTIDO CONTRARIO A LAS AGUJAS DEL RELOJ SE DIERON PARA ABRIR EL DISPOSITIVO? 2. ¿HUBO ALGUNA DIFICULTAD PARA EXTRAER EL DISPOSITIVO? NO. ¿SE CONFIRMÓ VISUALMENTE LA TRANSECCIÓN COMPLETA DE LA ARANDELA BLANCA DE SEPARACIÓN? SI. ¿SE INSPECCIONARON LOS DONUTS? EN CASO AFIRMATIVO, DESCRÍBALAS. SI DONAS COMPLETAS ¿SE OBSERVÓ ALGÚN PROBLEMA CON LA FORMACIÓN DE GRAPAS? EN CASO AFIRMATIVO, DESCRIBA LA FORMA Y LA UBICACIÓN. NO. ¿CREE EL CIRUJANO QUE LAS COMPLICACIONES POSTOPERATORIAS ESTUVIERON RELACIONADAS CON UNA SUPUESTA DEFICIENCIA DEL DISPOSITIVO O HUBO OTROS FACTORES QUE CONTRIBUYERON, COMO EL ESTADO DE LOS TEJIDOS DEL PACIENTE? LOS DOS FACTORES. ¿SE REALIZÓ UNA PRUEBA DE FUGAS? EN CASO AFIRMATIVO, ¿DE QUÉ TIPO Y CUÁL FUE EL RESULTADO? AZUL DE METILENO ¿SE VISUALIZÓ ENDOSCÓPICAMENTE LA LÍNEA DE GRAPAS DURANTE EL PROCEDIMIENTO QUIRÚRGICO INICIAL? NO ENDOSCÓPICAMENTE SINO POR LAPAROSCOPIA. ¿A LOS CUÁNTOS DÍAS DEL POSTOPERATORIO SE VIO LA FUGA 7 DÍAS QUÉ SE OBSERVÓ EN EL LUGAR DE LA FUGA EN LA REINTERVENCIÓN? REINGRESO CON DOLOR ABDOMINAL DISTENSIÓN Y LEUCOSITOSIS CON DESVIACIÓN IZQUIERDA, PEDIMOS TAC CON CONTRASTE ORAL SE VIO COLECCIÓN ALREDEDOR DE LA ANASTOMOSIS. ¿CÓMO SE TRATÓ LA FUGA? LAPAROTOMIA DRENAJE DE COLECCIONES AL DÍA SIGUIENTE SE COLOCÓ UNA PRÓTESIS ENDOSCOPIA Y SE VIO UNA ORIFICIO DE FÍSTULA POR ENDOSCOPIA. WHEN A TRANSLATION HAS BEEN RECEIVED BY THE AFFILIATE COUNTRY AN SUPPLEMENTAL MED WATCH WILL BE SENT WITH THE NEW ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/22/2024. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHAT WERE THE INDICATIONS FOR SURGICAL INTERVENTION? GASTRIC CANCER WHAT SURGICAL PROCEDURE WAS PERFORMED? LAPAROSCOPY PLUS TOTAL GASTRECTOMY DID THE PATIENT RECEIVE CHEMOTHERAPY OR PREOPERATIVE RADIATION THERAPY? YES WERE THERE ANY PROBLEMS WITH THE DEVICE IN THE INITIAL SURGICAL PROCEDURE? NO. WHICH HEALTHCARE PROFESSIONAL FIRED THE DEVICE AND WHAT IS THEIR EXPERIENCE WITH IT? DR (B)(6) AT WHAT POINT ON THE GREEN SPACE ADJUSTMENT SCALE WAS THE INDICATOR BEFORE THE SHOT (LOW B, MEDIUM B OR HIGH B)? HIGH DID THE HEALTHCARE PROFESSIONAL WAIT 15 SECONDS AFTER CLOSING THE DEVICE AND TIGHTEN IT AGAIN BEFORE FIRING? YES WERE THERE ANY PROBLEMS WITH THE USE/SHOOTING OF THE DEVICE? NO. WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE COMPLETED THE SHOOTING SEQUENCE? YES WAS THE GREEN CHECK MARK VISIBLE AT THE END OF COOKING? YES HOW MANY TURNS IN THE COUNTER CLOCKWISE DIRECTION WERE GIVEN TO OPEN THE DEVICE? 2 WAS THERE ANY DIFFICULTY REMOVING THE DEVICE? NO. WAS THE COMPLETE TRANSECTION OF THE WHITE SEPARATION WASHER VISUALLY CONFIRMED? YES WERE THE DONUTS INSPECTED? IF YES, DESCRIBE THEM. IF YOU DONATE COMPLETE WERE THERE ANY PROBLEMS WITH THE FORMATION OF STAPLES? IF YES, DESCRIBE THE SHAPE AND LOCATION. NO. DOES THE SURGEON BELIEVE THAT THE POSTOPERATIVE COMPLICATIONS WERE RELATED TO AN ALLEGED DEVICE DEFICIENCY OR WERE THERE OTHER CONTRIBUTING FACTORS, SUCH AS THE CONDITION OF THE PATIENT¿S TISSUES? THE TWO FACTORS WAS A LEAK TEST PERFORMED? IF SO, WHAT KIND AND WHAT WAS THE RESULT? METHYLENE BLUE WAS THE STAPLE LINE ENDOSCOPICALLY VISUALIZED DURING THE INITIAL SURGICAL PROCEDURE? NOT ENDOSCOPICALLY BUT BY LAPAROSCOPY HOW MANY DAYS AFTER SURGERY WAS THE LEAK SEEN 7 DAYS WHAT WAS OBSERVED AT THE SITE OF THE LEAK IN THE REINTERVENTION? RE-ADMISSION WITH ABDOMINAL PAIN DISTENSION AND LEUCOSITOSIS WITH LEFT DEVIATION, WE ORDERED CT WITH ORAL CONTRAST WAS SEEN COLLECTION AROUND THE ANASTOMOSIS HOW WAS THE ESCAPE TREATED? THE NEXT DAY, A PROSTHESIS ENDOSCOPY WAS PLACED AND A FISTULA HOLE WAS SEEN BY ENDOSCOPY.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 2/27/2024. D4 BATCH # UNK. B3: ONLY EVENT YEAR KNOWN: 2024. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THERE WAS AN ADVERSE EFFECT AFTER THE USE OF THE DEVICE, THE SURGEON HAD TO INTERVENE THE PATIENT DUE TO A FISTULA IN THE STAPLE LINE. THE PATIENT DID EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING. SURGICAL REINTERVENTION DUE TO LEAK DUE TO FISTULA IN THE STAPLE LINE, THERE WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657248 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention