BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16544924 · Received March 15, 2023

    Report

    Report Number
    1223422-2022-00018
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 13, 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

    THE SUBJECT SUFFERED FROM A NEOPLASM OF THE LOWER RECTUM, SO AN ABDOMINOPERINEAL ROBOTIC AMPUTATION OF THE RECTUM WAS PERFORMED ON A PRONE POSITION LAPAROSCOPICALLY. THREE ROBOTIC TROCARS WERE PERFORMED, ONE IN THE RIGHT FLANK, ONE IN THE LEFT FLANK AND ONE IN THE SUPRAPUBIC AREA. DURING THE SURGERY, THE ROOT OF THE INFERIOR MESENTERIC ARTERY AND VEIN ARE LIGATED WITH HEM-O-LOCK. THE CLOSURE WAS PERFORMED AT PERINEAL LEVEL WITH PERMACOL MESH AND FIXED WITH PROLENE STITCHES. THE AMPUTATION LASTED A TOTAL OF 9 HOURS AND WAS SUCCESSFULLY PERFORMED. AT THE END OF THE SURGERY, A SIGNIFICANT THORACIC-FACIAL SUBCUTANEOUS EMPHYSEMA WAS OBSERVED DUE TO THE LONG SURGICAL PROCEDURE OF 9 HOURS DURATION, WITH PNEUMOPERITONEUM LEAKAGE. THE SUBJECT WAS ADMITTED TO THE ICU AREA INTUBATED AND SINCE THE PATIENT HAD GOOD VENTILATORY MECHANICS, WITH ADEQUATE GAS EXCHANGE, EXTUBATION WAS DECIDED THE FOLLOWING DAY AFTER RULING OUT THE PRESENCE OF PNEUMOTHORAX ON X-RAY AND A POSITIVE LEAK TEST FOR AIRWAY PATENCY. THE PATIENT COMPLETED THE RESPIRATORY REHABILITATION PROGRAM DURING HIS HOSPITAL STAY WITHOUT FURTHER COMPLICATIONS. ACCORDING TO THE INVESTIGATOR´S CRITERIA, THE SAE HAS BEEN DETERMINED TO BE RELATED TO THE PROCEDURE (CAUSAL), BUT NOT RELATED TO THE INVESTIGATIONAL DEVICE.

    Description of Event or Problem · 0

    THE DATE OF THE SAE ONSET WAS ON (B)(6) 2023, BUT THE SITE WAS AWARE OF THIS EVENT BY THE END OF LAST WEEK (10MAR2023), REPORTING THIS INFORMATION TO US EARLY THIS MORNING. THE REPORTED SAE HAS BEEN DESCRIBED AS SUBCUTANEOUS EMPHYSEMA, WHICH LED TO A MEDICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016288 M/L-10 MULTI-FIRE CLIP APPLIER, REUSABLE MANUAL DETACHABLE SURGICAL INSTRUMENTS GEI MICROLINE SURGICAL 1002 00811099010388

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R