BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7723658 · Received July 26, 2018

    Report

    Report Number
    2210968-2018-74645
    Event Type
    Injury
    Date Received
    July 26, 2018
    Report Date
    July 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT USED IN THIS PROCEDURE? CITATION: TECH COLOPROCTOL (2014) 18:1003¿1007; DOI 10.1007/S10151-014-1137-9 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: PERINEAL STAPLED PROLAPSE RESECTION (PSPR) IN ELDERLY PATIENTS FOR EXTERNAL RECTAL PROLAPSE: EARLY EXPERIENCE AUTHOR : E. RAM ¿ H. KRISSI ¿ A. ZBAR ¿ E. ATAR ¿ S. JOUBRAN ¿ L. RATH-WOLFSON. CITATION: TECH COLOPROCTOL (2014) 18:1003¿1007; DOI 10.1007/S10151-014-1137-9 THE STUDY AIMED TO REPORT THE PRELIMINARY RESULTS OF THE PERINEAL STAPLED PROLAPSE RESECTION (PSPR) TECHNIQUE IN THE RESECTION OF THE FULL-THICKNESS EXTERNAL RECTAL PROLAPSE USING A NEW RELOADABLE CONTOUR TRANSTAR STAPLE DEVICE. BETWEEN APR2010 AND OCT2011, 14 ELDERLY PATIENTS (N=1 MALE AND N=13 FEMALE) WITH A FULL-THICKNESS EXTERNAL RECTAL PROLAPSE OF UP TO 10CM IN LENGTH UNDERWENT RESECTION USING THE NEW RELOADABLE CONTOUR TRANSTAR STAPLER. IN THE PROCEDURE, THE OPERATION COMMENCED WITH A LATERAL DIVISION OF THE PROLAPSE USING TLC75 LINEAR STAPLER. THE CONTOUR TRANSTAR WAS POSITIONED CORRECTLY AND STAPLER WAS FIRED WITH TRACTION ON THE PROLAPSE WAITING 30 SECONDS FOR TISSUE COMPRESSION AND HEMOSTASIS. THE STAPLE LINE WAS ROUTINELY COMPLETELY OVERSEWN WITH VICRYL 2/0 SUTURES TO ENSURE ITS INTEGRITY AND FOR HEMOSTASIS. POSTOPERATIVELY, FOUR PATIENTS HAD EARLY RECURRENT RECTAL PROLAPSE AFTER 1, 2, 4 AND 6 MONTHS; EACH SUBSEQUENTLY UNDERWENT AN ALTEMEIER PROCEDURE. PSPR IS SAFER, FASTER AND EASIER TO PERFORM THAN OTHER CONVENTIONAL PERINEAL PROLAPSE PROCEDURES AND IS SUITABLE FOR ELDERLY, HIGH-RISK PATIENTS FOR WHOM AND ABDOMINAL APPROACH UNDER GENERAL ANESTHESIA IS NO ADVISABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563495 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention