BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 8696248 · Received June 13, 2019

    Report

    Report Number
    2210968-2019-82711
    Event Type
    Injury
    Date Received
    June 13, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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: WORLD J SURG (2008) 32:1110¿1115; DOI 10.1007/S00268-008-9540-X - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : STAPLED TRANSANAL RECTAL RESECTION FOR OUTLET OBSTRUCTION SYNDROME: RESULTS AND FOLLOW-UP" AUTHOR : MARCO FRASCIO, CESARE STABILINI , BARBARA RICCI , PAOLO MARINO , ROSARIO FORNARO , LUIGI DE SALVO , FRANCESCA MANDOLFINO , FABRIZIO LAZZARA , EZIO GIANETTA. CITATION: WORLD J SURG (2008) 32:1110¿1115; DOI 10.1007/S00268-008-9540-X. THIS PROSPECTIVE STUDY WAS DESIGNED TO ASSESS SAFETY AND EFFECTIVENESS OF STAPLED TRANSANAL RECTAL RESECTION (STARR) IN A CAREFULLY SELECTED SERIES OF PATIENTS AFFECTED BY OUTLET OBSTRUCTION SYNDROME (OOS) RESULTING FROM A COMBINATION OF INTUSSUSCEPTION AND RECTOCELE. FROM JUL2000 TO MAR2007, 25 PATIENTS (N=19 FEMALE AND N=6 MALE; MEAN AGE AT SURGERY 55 ± 16.1 YEARS) WITH OOS IN WHOM A COMBINATION OF INTUSSUSCEPTION AND RECTOCELE WERE INCLUDED IN THE STUDY. IN THE PROCEDURE, TWO OR THREE SEPARATE ONE-HALF PURSE-STRING SUTURES (PROLENE 2-0) WERE INSERTED ABOVE THE HEMORRHOIDAL APEX TO INCLUDE THE TOP OF RECTOCELE AND INTERNAL RECTAL PROLAPSE. THE 33-MM CIRCULAR STAPLER SPECIFICALLY DESIGNED FOR THIS PROCEDURE (PPH-01, ETHICON ENDO-SURGERY, INC., POMEZIA, ITALY) WAS OPENED, AND THE ANVIL PLACED ABOVE THE ANTERIOR ONE-HALF PURSE STRINGS. THE PROCEDURE WAS THEN REPEATED FOR THE POSTERIOR RECTAL WALL. ON THE THIRD POSTOPERATIVE DAY, THE SECOND PATIENT IN THE PRESENT SERIES, IN WHOM REINFORCEMENT OF THE SUTURE LINE WAS NOT CARRIED OUT, EXPERIENCED MASSIVE RECTAL BLEEDING REQUIRING TRANSFUSION AND RE-INTERVENTION. EARLY POSTOPERATIVE GENERAL COMPLICATION INCLUDED FEVER OF UNKNOWN ORIGIN (N=1). LESS PAIN WAS REPORTED WITH NO PATIENT EXCEEDED THE 90MG DOSE OF KETOROLAC IN THE FIRST POSTOPERATIVE WEEK. LATE SPECIFIC COMPLICATIONS INCLUDED URGE TO DEFECATE (N=3) AND INCONTINENCE TO FLATUS (N=8). STARR SEEMS TO GIVE SEVERAL BENEFITS: IT IS TECHNICALLY EASIER THAN TRADITIONAL PROCEDURES, OPERATIVE TIME AND HOSPITAL STAY ARE SHORT, POSTOPERATIVE PAIN IS MINIMAL, AND TIME TO RESUMPTION OF NORMAL ACTIVITY IS SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489772 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention