BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO GIA SULU

    MDR report key: 12238958 · Received July 28, 2021

    Report

    Report Number
    1219930-2021-03063
    Event Type
    Injury
    Date Received
    July 28, 2021
    Date of Event
    February 13, 2021
    Report Date
    July 28, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: UNMASKING THE GREAT MASQUERADERS: CONCURRENT ISOLATED LARGE CECAL ENDOMETRIOMA AND SOLITARY EXTRA-UTERINE RETROPERITONEAL CELLULAR LEIOMYOMA ¿ A CASE REPORT WITH REVIEW OF LITERATURE SOURCE: INTERNATIONAL JOURNAL OF SURGERY CASE REPORTS 80 (2021) 105666. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE, A STUDY WAS PERFORMED TO A (B)(6) YEAR OLD, WOMAN WHO UNDERWENT LAPAROSCOPIC EXCISION OF CONCURRENT ISOLATED LARGE CECAL ENDOMETRIOMA AND EXTRA-UTERINE CELLULAR LEIOMYOMA USING A LINEAR STAPLER. THE PATIENT HAD STAPLE LINE BLEEDING AND WAS CONTROLLED BY AN UNDER-RUNNING STITCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136888 UNKNOWN ENDO GIA SULU STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN UNKNOWN ENDO GIA SULU

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention