BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EEA

    MDR report key: 12911253 · Received December 1, 2021

    Report

    Report Number
    2647580-2021-04083
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    September 28, 2021
    Report Date
    December 1, 2021
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: TRANSANAL TOTAL MESORECTAL EXCISION AND TRANSABDOMINAL ROBOTIC SURGERY FOR RECTAL CANCER: A RETROSPECTIVE STUDY SOURCE: ANNALS OF MEDICINE AND SURGERY 70 (2021) 102902. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT TRANSABDOMINAL ROBOTIC SURGERY AND LAPAROSCOPIC TRANSANAL TOTAL MESORECTAL EXCISION FOR RECTAL CANCER BETWEEN SEPTEMBER 2018 AND APRIL 2020. FOR LOW ANTERIOR RESECTION, AN END-TO-END ANASTOMOSIS WAS PERFORMED WITH A CIRCULAR STAPLER. EITHER AN STAPLER (25MM 4.8MM STAPLES) OR A OTHER STAPLER FROM OTHER MANUFACTURER WERE USED. THERE WERE 6 PATIENTS IN THE STUDY AND 4 PATIENTS UNDERWENT A STAPLED ANASTOMOSIS. ONE PATIENT IN THE STAPLED GROUP HAD AN ANASTOMOSIS LEAK AND WAS TREATED WITH ULTRASOUND AND COMPUTED TOMOGRAPHY-GUIDED DRAINAGE AND ANTIBIOTICS. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED: URINARY RETENTION AND ISCHEMIC COLITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1809119 UNKNOWN EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO UNKNOWN EEA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other