BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 10975030 · Received December 9, 2020

    Report

    Report Number
    1717344-2020-01485
    Event Type
    Injury
    Date Received
    December 9, 2020
    Date of Event
    December 18, 2015
    Report Date
    December 9, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: MANAGEMENT OF ADRENAL INCIDENTALOMA BY LAPAROSCOPIC TRANSPERITONEAL ANTERIOR AND SUBMESOCOLIC APPROACH SOURCE: LANGENBECKS ARCH SURG (2016) 401:71¿79 PUBLISHED ONLINE: 18 DECEMBER 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, FROM JANUARY 1994 TO DECEMBER 2012, 393 PATIENTS UNDERWENT LAPAROSCOPIC ADRENALECTOMY(LA). 117 OF THESE WERE FOR ADRENAL MASSES (ADRENAL INCIDENTALOMA) AI. SIXTY-SEVEN (57.26 %) AND 50 (42.73 %) PATIENTS UNDERWENT RIGHT AND LEFT ADRENALECTOMY, RESPECTIVELY. THE TRANSPERITONEAL ANTERIOR APPROACH WAS USED IN ALL 67 PATIENTS WITH RIGHT LESIONS (57.26 %) (GROUP A) AND IN 13 PATIENTS WITH LEFT-SIDED LESIONS (11.11 %) (GROUP B). THE TRANSPERITONEAL ANTERIOR SUBMESOCOLIC APPROACH WAS USED IN THE REMAINING 37 LEFT-SIDED LESIONS (31.62 %) (GROUP C). POST-OPERATIVELY, 1/67 PATIENTS HAD HEMOPERITONEUM AFTER RIGHT LA TREATED WITH REOPERATION BY LAPAROSCOPY. POSTOPERATIVE BLOOD TRANSFUSIONS WERE REQUIRED IN TWO PATIENTS (2/ 67, 8.3 %) WHO UNDERWENT RIGHT LA. MANAGEMENT OF ADRENAL INCIDENTALOMA BY LAPAROSCOPIC TRANSPERITONEAL ANTERIOR AND SUBMESOCOLIC APPROACH: ANDREA BALLA; 2015; SPRINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445158 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention