BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6959205 · Received October 18, 2017

    Report

    Report Number
    3005075853-2017-05524
    Event Type
    Injury
    Date Received
    October 18, 2017
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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. DOES THE SURGEON BELIEVE THE POST-OPERATIVE COMPLICATIONS OUTLINED IN THIS JOURNAL ARTICLE ARE ASSOCIATED WITH AN ALLEGED DEFICIENCY OF AN ETHICON PRODUCT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW OF JOURNAL ARTICLE: LAPAROSCOPIC SLEEVE GASTRECTOMY WITH 27 VERSUS 39 FR BOUGIE CALIBRATION: A RANDOMIZED CONTROLLED TRIAL. AUTHORS: PATRICIO CAL, LUCIANO DELUCA, TOMAS JAKOB, EZEQUIEL FERNANDEZ. CITATION: SURGICAL ENDOSCOPY 2016;30:1812-1815. DOI 10.1007/S00464-015-4450-0. THE OBJECTIVE OF THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL WAS TO COMPARE LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG) OUTCOMES USING DIFFERENT CALIBRATING BOUGIE DIAMETERS. FROM OCTOBER 2011 TO DECEMBER 2012, 126 PATIENTS UNDERGOING LSG WERE RANDOMIZED TO INTRAOPERATIVE CALIBRATION WITH EITHER A 27 FR (GROUP A, N=64, MEAN AGE 41.9 YEARS (RANGE 26-69, MEAN BMI 44.3 KG/M2 (RANGE 40-49.8), 87.1% FEMALE) OR A 39 FR (GROUP B, N=64, MEAN AGE 42.4 YEARS (RANGE 20-64), MEAN BMI 43.5 KG/M2 (RANGE 40-50), 84.3% FEMALE) SEMIRIGID BOUGIE. A LAPAROSCOPIC LINEAR CUTTING STAPLER WAS USED (ECHELON ENDOPATH EC45 OR EC60). BLUE LOADS (3.5 MM) WERE PREFERRED ALTHOUGH SOMETIMES GOLD (3.8 MM) OR GREEN (4.1 MM) LOADS WERE USED ON THE ANTRUM ACCORDING TO THE ESTIMATED TISSUE THICKNESS. TWO PATIENTS HAD LEAKS, ONE IN EACH GROUP. AFTER A 24-H READMISSION, BOTH WERE TREATED WITH ORAL FEEDING AS OUTPATIENTS. THE PATIENT FROM GROUP A WAS TREATED CONSERVATIVELY BY LEAVING SURGICAL DRAIN IN PLACE FOR A MONTH, WHEREAS THE PATIENT FROM GROUP B REQUIRED PERCUTANEOUS DRAINAGE. BOTH RESOLVED WITHIN 45 DAYS OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738027 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention