BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 9965154 · Received April 15, 2020

    Report

    Report Number
    3005075853-2020-02183
    Event Type
    Injury
    Date Received
    April 15, 2020
    Report Date
    March 31, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012405
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNKNOWN. BATCH # UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT IS THE SPECIFIC NUMBER OF PATIENTS WHO UTILIZED THE CONTOUR CURVED CUTTER STAPLER (GREEN) (ETHICON) AND EXPERIENCED POST-OPERATIVE BLEEDING?

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ANASTOMOTIC LEAKAGE FOLLOWING LAPAROSCOPIC RESECTION OF LOW AND MID RECTAL CANCER. AUTHORS: MOSTAFA SHALABY, WALEED THABET, FRANCESCO RULLI, FRANCESCO PALMIERI, FEDERICA SARACENO, ILARIA CAPUANO, ORESTE BUONOMO, GABRIELLA GIARRATANO, GIUSEPPE PETRELLA, MOSAAD MORSHED, MOHAMED FARID, PIERPAOLO SILERI. CITATION: ANN. ITAL. CHIR., 2019 90, 1: 57-67. ANASTOMOTIC LEAKAGE IS CONSIDERED THE COMMONEST MAJOR COMPLICATION AFTER SURGERY FOR RECTAL CANCER. THE DATA OF 59 PATIENTS (27 MALE AND 32 FEMALE; MEAN AGE: 63.49±11.16 YEARS; MEAN BMI: 24.95±3.56 KG/M2) WHO UNDERWENT CURATIVE LAPAROSCOPIC LOW ANTERIOR RESECTION (LAR) OR ULTRALOW ANTERIOR RESECTION (ULAR) WITH COLORECTAL OR COLOANAL ANASTOMOSES FOR BIOPSY PROVEN PRIMARY RECTAL CANCER FROM JANUARY 2015 UNTIL JANUARY 2017 HAD BEEN COLLECTED AND ANALYZED PROSPECTIVELY. DURING THE PROCEDURE, TRANSECTION OF THE RECTUM WAS DONE WITH 30 MM ARTICULATING MEDIUM/THICK RELOAD WITH TRI-STAPLE TECHNOLOGY LOADED WITH VIOLET CARTILAGE 60 MM OR CONTOUR CURVED CUTTER STAPLER GREEN (ETHICON). REPORTED COMPLICATION INCLUDED POSTOPERATIVE BLEEDING (N-?) IN WHICH THE PATIENTS REQUIRED BLOOD TRANSFUSION IN CONCLUSION, STANDARDIZATION OF A DEFINITION, AS WELL AS, CRITERIA FOR THE DIAGNOSIS OF AL, WILL HELP IN COMPARISON OF THE RESULTS AND THE SURGICAL TECHNIQUES IN ORDER TO OPTIMIZE THE REQUIRED CARE OFFERED TO RECTAL CANCER PATIENTS. ON EXPERT HANDS, IT IS FEASIBLE TO PERFORM A LAPAROSCOPIC SPHINCTER-SAVING TOTAL MESORECTAL EXCISION, ADDITIONALLY, IT PROVIDES THE ADVANTAGES OF A CLEAR VIEW OF THE DEEP PELVIS AND FACILITATES A PRECISE SHARP DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428583 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. CS40G 10705036012405

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention