BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ENDO CLIP APPLIER

    MDR report key: 12135669 · Received July 8, 2021

    Report

    Report Number
    9612501-2021-01116
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    November 8, 2020
    Report Date
    July 8, 2021
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    FZP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: PURE LAPAROSCOPIC DONOR NEPHRECTOMY WITHOUT ROUTINE DRAINAGE DOES NOT INCREASE POSTOPERATIVE MORBIDITY SOURCE: INVESTIG CLIN UROL 2021;62:172-179 PUBLISHED ONLINE: 10 FEBRUARY, 2021.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE, A STUDY COMPARED OUTCOMES OF PATIENTS WHO UNDERWENT PURE LAPAROSCOPIC DONOR NEPHRECTOMY WITH AND WITHOUT ROUTINE DRAIN INSERTION BETWEEN JULY 2014 AND OCTOBER 2018. THERE WERE 80 PATIENTS IN THE DRAIN GROUP AND 98 PATIENTS IN THE NON-DRAIN GROUP. THE RENAL ARTERY WAS CLAMPED WITH 1 OR 2 CLIPS FROM DIFFERENT MANUFACTURER AND 2 LARGE CLIP APPLIERS. COMPLICATIONS INCLUDED: INTRAOPERATIVE BLEEDING, ARTERIAL INJURY, AND ONE PATIENT WITH DISLOCATION OF CLIP FROM VESSELS. OTHER COMPLICATIONS WERE NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036252 UNKNOWN ENDO CLIP APPLIER CLIP, IMPLANTABLE FZP DAVIS & GECK CARIBE LTD UNKNOWN ENDO CLIP APPLIER

    Patients

    Seq Age Sex Outcome Treatment
    1 Other