BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE

    MDR report key: 16523406 · Received March 10, 2023

    Report

    Report Number
    1223422-2022-00017
    Event Type
    Injury
    Date Received
    March 10, 2023
    Date of Event
    February 26, 2023
    Report Date
    March 10, 2023
    Manufacturer
    MICROLINE SURGICAL
    Product Code
    GEI
    UDI-DI
    00811099010388
    PMA / PMN Number
    K013695
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS PATIENT SUFFERED FROM SEVERE DEHYDRATION FROM HIGH ILEOSTOMY OUTPUT. THIS IS THE MOST COMMON COMPLICATION FOLLOWING THE CREATION OF A NEW ILEOSTOMY. THE DEVICE HAS NO RELATION TO THIS.

    Description of Event or Problem · 0

    THE PROCEDURES PERFORMED ON THIS SUBJECT WERE A ROBOTIC PROCTECTOMY, ILEOANAL RESERVOIR AND A PROTECTIVE ILEOSTOMY. AS MENTIONED IN MY PREVIOUS COMMUNICATION, THE SUBJECT WAS PREVIOUSLY DIAGNOSED WITH ULCERATIVE COLITIS. THE TECHNIQUES COMPLETED DURING THE SURGERY ARE INDICATED BELOW: TROCAR INTRODUCTION. RELEASE OF MUCOSAL FISTULA. POSTERIOR AND LATERAL MESORECTAL DISSECTION WITH NERVE PRESERVATION UP TO THE PELVIC FLOOR. ANTERIOR DISSECTION OF THE RECTUM SEPARATING THE RECTOVAGINAL SEPTUM UP TO THE PELVIC FLOOR. RECTAL SECTION WITH TWO 60MM GREEN ROBOTIC ENDO STAPLER LOADS. RELEASE OF SMALL BOWEL MESENTERY ROOT TO DUODENUM. SECTION OF TERMINAL ILEUM WITH ROBOTIC ENDOGRAPATOR. EXTRACTION OF THE PIECE BY PFANNENSTIEL INCISION. EXTRACORPOREAL CONFECTION OF ILEOANAL RESERVOIR OF ABOUT 13-14 CM (3 LOADS 60 MM BEIGE SIGNIA). REINFORCEMENT OF THE ANTERIOR FACE WITH LOOSE VYCRIL STITCHES. MECHANICAL CIRCULAR RECTAL RESERVOIR ANASTOMOSIS 29 MM 4.8MM STAPLE HEIGHT. ANASTOMOSIS ABOUT 4-5 CM FROM ANAL MARGIN. LOOP ILEOSTOMY. CLOSURE OF INCISIONS. 20 DAYS AFTER THE SURGERY, THE SUBJECT GOES TO THE HOSPITAL REFERRING ACUTE PAIN IN THE ABDOMEN, WITH DAILY NAUSEA AND VOMITING (USUALLY AT NIGHT). THE SUBJECT HAS LOST APPROXIMATELY 7 KILOGRAMS IN TWO WEEKS, AND SHE ALSO REFERRED ASTHENIA AND LOW ARTERIAL PRESSURE (80/60MM HG). LIQUID STOOL, WITH THE EMPTINESS OF THE RESERVOIR EVERY HOUR. NO FEVER WAS REPORTED. NO OTHER SYMPTOMS ASSOCIATED. THE FINAL DIAGNOSIS IS "DEHYDRATION IN SUBJECT PORTING A STOMA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921846 M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL 1002 00811099010388

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Hospitalization