BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    PNEUMOLINER

    MDR report key: 12468188 · Received September 14, 2021

    Report

    Report Number
    9616720-2021-00001
    Event Type
    Injury
    Date Received
    September 14, 2021
    Date of Event
    September 3, 2021
    Report Date
    September 14, 2021
    Manufacturer
    ADVANCED SURGICAL CONCEPTS LTD.
    Product Code
    PMU
    PMA / PMN Number
    K192898
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON DESCRIBED THE LSH AND CONTAINED POWER MORCELLATION PROCEDURE UNDERTAKEN AND THE EVENTS THAT LED TO THE PATIENT INJURY; AN ABRASION OF THE MESENTERY REQUIRING A COUPLE OF STITCHES AND A MINOR SEROSAL INJURY (A BREACH OF INTEGRITY OF THE VISCERAL PERITONEUM, THE OUTERMOST COVERING OF THE BOWEL WALL) THAT DID NOT REQUIRE ANY STITCHES. UPON DEPLOYMENT OF THE BAG FROM THE INTRODUCER THE SURGEON NOTED THAT THE BAG MATERIAL WAS ON TOP OF THE OPEN MOUTH OF THE BAG. SPECIFICALLY, THE BAG DEPLOYED UPSIDE DOWN. THE BAG SHOULD DEPLOY WITH THE BAG MATERIAL UNDERNEATH THE OPEN MOUTH OF THE BAG. THE SURGEON DESCRIBED THAT THE BAG MATERIAL INTERFERED WITH HIS ENCAPSULATION OF THE SPECIMEN/CLOSURE OF THE BAG. HE STATED THAT THE A LOOP OF SMALL BOWEL WAS BETWEEN THE BAG MATERIAL AND THE OPENING RING AT THE 6 O'CLOCK POSITION. THIS WAS NOT IDENTIFIED BY THE SURGEON AND THE SURGEON PROCEED TO CLOSE THE BAG BY PULLING ON THE TETHER. THIS TRAPPED/PINCHED THE LOOP OF BOWEL BETWEEN THE OPENING RING AND THE BOOT AT THE INCISION. THIS WAS IMMEDIATELY NOTED BY THE SURGEON WHEN HE WENT TO OPEN THE MOUTH OF THE BAG. THE LOOP OF SMALL BOWEL WAS RELEASED FROM THE INCISION AND THE CONTAINED POWER MORCELLATION WAS COMPLETED WITHOUT FURTHER INCIDENT. THE SURGEON CONFIRMED THAT THE BAG INTEGRITY WAS NOT COMPROMISED. UPON REMOVAL OF THE BAG THE SURGEON REATTACHED THE QUADPORT+ BOOT (USED TO PERFORM THE SINGLE PORT LSH) TO CHECK FOR HEMOSTASIS AND UNDERTOOK AN EXAMINATION OF THE BOWEL. HE WAS ABLE TO DO THIS EXTERNALLY THROUGH THE INCISION AND IDENTIFIED THE SECTION OF SMALL BOWEL AND MESENTERY THAT HAD BEEN MOMENTARILY TRAPPED/PINCHED. THE MESENTERY HAD SOME BRIGHT RED BLEEDING THAT THE SURGEON REPAIRED WITH A COUPLE OF STITCHES. NO FURTHER INTERVENTION WAS REQUIRED. THE PATIENT MADE A FULL RECOVERY AND LEFT THE HOSPITAL ON THE SAME DAY AS THE PROCEDURE. THE SURGEON HAS SEEN THE PATIENT TWICE WITH NO SEQUALAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364990 PNEUMOLINER LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM PMU ADVANCED SURGICAL CONCEPTS LTD. WA90500US 667060

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death| R