BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENPLACE

    MDR report key: 18310808 · Received December 12, 2023

    Report

    Report Number
    3010892271-2023-00007
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 24, 2023
    Manufacturer
    FEMSELECT LTD.
    Product Code
    PBQ
    PMA / PMN Number
    K160569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERGONE ENPLACE REPAIR AND DEVELOPED AN APICAL FAILURE IN A MATTER OF WEEKS. AFTER A LONG DISCUSSION OF MANAGEMENT OPTIONS, SHE ELECTED FOR ENPLACE ONCE AGAIN. OF NOTE, ANATOMICALLY, HER UTERUS WAS VERY ATROPHIC. I WAS CONVINCED THAT THE FAILURE WAS DUE TO LACK OF ADEQUATE TISSUE BITES OF THE CERVIX WITH THE SUTURE. AS SUCH, ON THE REPEAT, I MADE GREATER EFFORT TO INVOLVE THE CERVIX IN THE PASSES OF NEEDLE BY TAKING MORE SUBSTANTIAL BITES. IN THE END OF THE CASE, THERE WAS EXCELLENT LIFT OF THE APEX TISSUE. I WAS TOLD ABOUT 4-5 DAYS LATER THAT SHE HAD BEEN ADMITTED WITH SBO. THE SURGEON FOUND THAT THE SUTURE HAD CAUGHT A SHORT SEGMENT OF THE ILEUM. THE WAS EXCISED AND REPAIRED. SHE IS NOW RECOVERING WELL. CASE DATE: (B)(6) 2023. FACILITY: (B)(6). THE PATIENT INJURY OCCURRED DURING THE HYSTEROPEXY PROCEDURE, WHICH IS NOT DEVICE RELATED. THE SUTURE PLACEMENT THROUGH THE SMALL BOWEL COULD HAVE OCCURRED, REGARDLESS OF THE APPROACH FOR SACROSPINUS LIGAMENT SUTURE PLACEMENT. THE SMALL BOWEL INJURY OCCURRED DURING THE SUSPENSION OF THE CERVIX WHICH IS A ROUTINE STEP IN HYSTEROPEXY, REGARDLESS OF SURGICAL TOOLS EMPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1579873 ENPLACE FIXATION, NON-ABSORBABLE FOR PELVIC USE PBQ FEMSELECT LTD. ENPLACE UNKNOWEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention