BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8817785 · Received July 23, 2019

    Report

    Report Number
    3005075853-2019-20677
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 27, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2009. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: RETROPERITONEAL SEPSIS WITH MEDIASTINAL AND SUBCUTANEOUS EMPHYSEMA COMPLICATING STAPLED TRANSANAL RECTAL RESECTION (STARR) AUTHOR: V.M. STOLFI, C. MICOSSI, P. SILERI, M. VENZA, A. GASPARI CITATION: TECH COLOPROCTOL. 2009; 13: 69¿71. DOI: 10.1007/S10151-009-0465-7. THE AUTHORS PRESENTED A CASE OF SEVERE RETROPERITONEAL SEPSIS WITH MEDIASTINAL AND SUBCUTANEOUS EMPHYSEMA COMPLICATING STARR, TREATED BY TRANSPERINEAL PELVIC DRAINAGE, AND A LOOP SIGMOID COLOSTOMY. A (B)(6)-YEAR-OLD WOMAN AFFECTED BY RECTAL INTUSSUSCEPTION AND RECTOCELE ASSOCIATED WITH OBSTRUCTED DEFECATION SYNDROME WAS PRESENTED TO THE UNIT. SHE UNDERWENT DEFECOGRAPHY, ANORECTAL MANOMETRY AND COLONOSCOPY, WHICH CONFIRMED THE DIAGNOSIS. THE PATIENT WAS TREATED BY A STANDARD STARR PROCEDURE USING TWO PPH-01 STAPLERS (ETHICON). REPORTED COMPLICATIONS INCLUDED SEVERE DIARRHEA, FEVER, DEEP PERINEAL AND LOW ABDOMINAL PAIN, AND GROWTH OF ESCHERICHIA COLI, IN WHICH BROAD SPECTRUM INTRAVENOUS ANTIBIOTIC TREATMENT WAS IMMEDIATELY STARTED. DESPITE TREATMENT, CT SCAN SHOWED BALLOTTABLE RIGHT PERIANAL AND GLUTEAL MASS WITH HYPEREMIC AND WARM SKIN, GENERALIZED RETROPERITONEAL AND MEDIASTINAL EMPHYSEMA, PERIRECTAL FLUID COLLECTION WITH SUBCUTANEOUS EMPHYSEMA, PARTIAL DEHISCENCE OF THE POSTERIOR RECTORECTAL SUTURE LINE, AND RIGHT ISCHIORECTAL PHLEGMON WITH GAS COLLECTION. THE AUTHORS PERFORMED A LOOP SIGMOID COLOSTOMY AND CLOSED THE ABDOMEN. THEN THE AUTHORS DRAINED THE ISCHIORECTAL AND SUPRALEVATOR ABSCESSES TRANSPERINEALLY POSITIONING A LARGE-BORE MUSHROOM CATHETER IN THE RIGHT ISCHIORECTAL SPACE AND A SECOND ONE THROUGH THE LEVATOR ANI DRAINING THE PERIRECTAL FLUID COLLECTION. IN CONCLUSION, ANASTOMOTIC DEHISCENCE WITH SEVERE RETROPERITONEAL SEPSIS AFTER THE STARR PROCEDURE IS A DRAMATIC AND LIFE-THREATENING COMPLICATION, AND MAY OCCUR EVEN IF A CORRECT TECHNIQUE WAS USED. IN THE AUTHOR¿S EXPERIENCE, IMMEDIATE FECAL DIVERSION AND DRAINAGE OF THE PELVIC ABSCESS IS THE TREATMENT OF CHOICE. IN THE INTEREST OF PATIENTS AND SURGEONS, IT IS IMPERATIVE THAT A NEW SURGICAL PROCEDURE SUCH AS STARR IS IMPLEMENTED IN A SAFE AND RESPONSIBLE MANNER. STARR IS INTENDED FOR BENIGN DISEASES SUCH AS OBSTRUCTED DEFECATION SYNDROME, WHICH MAY BE VERY UNCOMFORTABLE FOR PATIENTS, BUT DOES NOT BY ITSELF LEAD TO LIFE-THREATENING COMPLICATIONS. EXTREMELY ACCURATE INDICATIONS AND A PROFOUND KNOWLEDGE OF THE FIELD AND SPECIFIC SURGICAL PRACTICE IS IMPERATIVE IN PRACTICING THIS PROCEDURE IN ORDER TO MINIMIZE LIFE-THREATENING COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609412 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention