BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PNEUMOLINER

    MDR report key: 7497700 · Received May 9, 2018

    Report

    Report Number
    9616720-2017-00002
    Event Type
    Injury
    Date Received
    May 9, 2018
    Date of Event
    August 29, 2017
    Report Date
    August 31, 2017
    Manufacturer
    ADVANCED SURGICAL CONCEPTS LTD
    Product Code
    PMU
    PMA / PMN Number
    DEN150028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON ASC'S INVESTIGATION OF THIS EVENT TO DATE, WHICH INCLUDED DISCUSSIONS WITH THE CLINICAL SPECIALIST IN ATTENDANCE AT THE CASE AND THE SURGEON, ASC BELIEVES THAT THIS EVENT WAS THE RESULT OF USER ERROR. BECAUSE IT IS UNCLEAR WHETHER OR THE EXTENT TO WHICH THE PNEUMOLINER CAUSED OR CONTRIBUTED TO THIS EVENT, ASC IS SUBMITTING THIS MDR OUT OF AN ABUNDANCE OF CAUTION TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    ON (B)(6) 2017, ASC BECAME AWARE OF THE FOLLOWING EVENT INVOLVING THE PNEUMOLINER (PL). THE PROCEDURE WAS A SUPRACERVICAL HYSTERECTOMY. IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO GRAB SOFT TISSUE AT THE BASE OF THE PL AND INADVERTENTLY GRABBED THE PL AND THE SMALL BOWEL AS WELL, WITH THE TENACULUM. THE SURGEON SAID THE PL PERFORMED AS INTENDED, UNROLLING AND INFLATING AND PROVIDING A LARGE SPACE FOR MORCELLATION. THERE WAS A LARGE CALCIFIED FIBROID WHICH SHE FOUND VERY HARD TO MORCELLATE. THE SURGEON GRABBED THE SIDE OF THE PL ALONG WITH THE TISSUE, WHICH SHE NOTICED WHEN DRAWING THE TISSUE TOWARDS THE MORCELLATOR. THE SURGEON COULD SEE A 5MM TEAR IN THE PL AND A LOOP OF SMALL BOWEL PUSHING INTO THE PL. THE SURGEON MARKED THE SECTION OF BOWEL THAT WAS DAMAGED, CLOSED OFF THE TEAR IN THE PL WITH A KELLY CLAMP AND HAND-MORCELLATED THE REMAINING FIBROID AT THE INCISION SITE. A GENERAL SURGEON THEN MADE THE REPAIR TO THE SECTION OF THE BOWEL THAT WAS DAMAGED DURING THE SAME SURGERY. THE SURGEON STATED THE PATIENT HAD MADE A FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341714 PNEUMOLINER LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM PMU ADVANCED SURGICAL CONCEPTS LTD WA90500US

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention