BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 7720549 · Received July 25, 2018

    Report

    Report Number
    3005075853-2018-11546
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    January 1, 2010
    Report Date
    June 28, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036012990
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE: LAPAROSCOPIC CORRECTION OF ENTEROCELE ASSOCIATED TO STAPLED. TRANSANAL RECTAL RESECTION FOR OBSTRUCTED DEFECATION SYNDROME. AUTHOR : ALFONSO CARRIERO & MARCELLO PICCHIO & JACOPO MARTELLUCCI & PASQUALE TALENTO & DOMENICO PALIMENTO & ERASMO SPAZIANI,2. CITATION: INT J COLORECTAL DIS. 2010; 25: 381¿387. DOI: 10.1007/S00384-009-0840-X. THE AUTHORS REPORTED THEIR EXPERIENCE OF CONCOMITANT LAPAROSCOPIC TREATMENT FOR ENTEROCELE AND STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR RECTOCELE AND/OR RECTAL PROLAPSE IN PATIENTS WITH COMPLEX OBSTRUCTED DEFECATION SYNDROME (ODS). FROM JUNE 2005 TO JUNE 2007, THE AUTHORS SUBMITTED 20 PATIENTS (19 FEMALES AND 1 MALE PATIENT; AGE RANGE: 36 TO 75 YEARS OLD) WITH ODS DUE TO RECTAL PROLAPSE AND/OR RECTOCELE, COMBINED WITH STABLE ENTEROCELE, TO STARR AND LAPAROSCOPIC CORRECTION OF THE ENTEROCELE. AFTER EXPOSURE OF THE PELVIS HOLDING BACK THE SMALL BOWEL, STARR PROCEDURE WAS PERFORMED. A TOTAL OF 16 PROCEDURES WERE PERFORMED WITH THE PPH-01 STAPLED ANOPLASTY KIT (ETHICON) AND 3 PROCEDURES WITH CONTOUR TRANSTAR (ETHICON). THE LAPAROSCOPIC PROCEDURE AIMED TO EXCISE THE ENTEROCELE SAC AND OBLITERATE DOUGLAS¿ CUL-DE-SAC. AFTER PROPER DISSECTION OF THE ENTIRE SAC WITH MONOPOLAR DIATHERMY, A RUNNING SUTURE OF THE PERITONEAL MARGINS WITH VICRYL 2-0 SUTURE WAS PERFORMED. REPORTED COMPLICATIONS INCLUDED RECTAL BLEEDING (N-1) WHICH WAS TREATED CONSERVATIVELY, RETROPNEUMOPERITONEUM (N-1) WHICH REQUIRED ANTIBIOTIC THERAPY FOR 7 DAYS AND THE EVENT RESOLVED AFTER, AND POST-OPERATIVE URGENCY NOT ASSOCIATED WITH PRE-OPERATIVE URGENCY (N-3). IT WAS CONCLUDED THAT THE COMBINATION OF STARR AND LAPAROSCOPY PROVIDES A SAFE AND EFFECTIVE METHOD TO TREAT ODS CAUSED BY RECTAL INTERNAL PROLAPSE AND/OR RECTOCELE AND COMBINED WITH ENTEROCELE AND OTHER PELVIC FLOOR ABNORMALITIES. LARGER STUDIES WITH LONG-TERM FOLLOW-UP ARE NECESSARY TO ASSESS THE RESULTS OF THIS NEW COMBINED SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560968 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036012990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention