BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    MDR report key: 8200797 · Received December 27, 2018

    Report

    Report Number
    2210968-2018-78060
    Event Type
    Injury
    Date Received
    December 27, 2018
    Report Date
    December 6, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GEA
    PMA / PMN Number
    K925914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: INT UROGYNECOL J. 2012; 23: 1137¿1139. DOI: 10.1007/S00192-012-1668-4 . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: CYSTOSCOPIC REMOVAL OF INTRAVESICAL SYNTHETIC MESH EXTRUSION WITH THE AID OF ENDOLOOP SUTURES AND ENDOSCOPIC SCISSORS: AUTHORS: JARED M. BIENIEK, TARA L. HOLSTE, RAISA O. PLATTE, VATCHE A. MINASSIAN CITATION: INT UROGYNECOL J. 2012; 23: 1137¿1139. DOI: 10.1007/S00192-012-1668-4. THE AUTHORS PRESENTED A CASE OF INTRAVESICAL POLYPROPYLENE MESH EXTRUSION FOLLOWING A COMBINED MESH KIT AND MIDURETHRAL SLING PLACEMENT. A NOVEL TRANSURETHRAL APPROACH, EMPLOYING VICRYL ENDOLOOP SUTURES (ETHICON) WITH ENDOSCOPIC SCISSORS, WAS USED TO RESECT THE PROTRUDING MESH LOCATED IN CLOSE PROXIMITY TO A URETERAL ORIFICE. A (B)(6) WOMAN WAS PRESENTED TO THE HOSPITAL WITH MESH EXTRUSION. IT WAS REPORTED THAT 4 YEARS PRIOR TO PRESENTATION, SHE UNDERWENT MESH KIT AND MID-URETHRAL SLING PLACEMENT. DURING THE OPERATIVE CYSTOSCOPY, A VICRYL ENDOLOOP SUTURE (ETHICON) WAS INTRODUCED INTO THE BLADDER ADJACENT TO THE CYSTOSCOPE AND PASSED UNDER THE BAND OF MESH. A SECOND ENDOLOOP SUTURE WAS NEXT SECURED AROUND THE REMAINING PORTION OF THE MESH AND SCISSORS USED TO EXCISE THE RIGHT EXIT SITE OF MESH. REMAINING MESH FIBERS WERE TRIMMED UNTIL NO FIBERS WERE SEEN. REPORTED COMPLICATIONS INCLUDED NECROTIC DEBRIS AT ONE OF THE MESH EXIT SITES AND TWO MINUSCULE FIBERS NEAR THE OTHER PREVIOUS MESH EXIT SITE. THE AUTHORS DESCRIBED A NOVEL TECHNIQUE FOR EXCISION OF INTRAVESICAL MESH EXTRUSION USING A TRANSURETHRAL APPROACH WITH ENDOLOOP SUTURES AND ENDOSCOPIC SCISSORS. BY AVOIDING THE USE OF AN ENERGY SOURCE, THE AUTHORS REDUCED POTENTIAL COMPLICATIONS RELATED TO INJURY OF SURROUNDING STRUCTURES WITHIN THE BLADDER WITH NO RECURRENCE OF MESH EXTRUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040278 ENDOLOOP LIGATURE UNKNOWN PRODUCT CANNULA, SURGICAL, GENERAL GEA ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention