BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8842960 · Received July 30, 2019

    Report

    Report Number
    3005075853-2019-20897
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    January 1, 2004
    Report Date
    July 11, 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
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2004. 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: PELVIC SEPSIS AFTER STAPLED HEMORRHOIDECTOMY AUTHORS: PATRICK PESSAUX, MD; EMILIE LERMITE, MD; JEAN-JACQUES TUECH, MD; OLIVIER BREHANT, MD; NICOLAS REGENET, MD; JEAN-PIERRE ARNAUD, MD CITATION: J AM COLL SURG. 2004; 199(5): 824-5. DOI: 10.1016/J.JAMCOLLSURG.2004.04.026. A PREVIOUSLY HEALTHY (B)(6) YEAR-OLD MAN UNDERWENT STAPLED HEMORRHOIDECTOMY DONE WITH PPH 01 33-MM ETHICON HEMORRHOIDAL CIRCULAR STAPLER (ETHICON). FOUR DAYS LATER, THE PATIENT WAS PRESENTED BACK AT THE EMERGENCY DEPARTMENT COMPLAINING OF RECTAL DISCOMFORT AND PERINEAL PAIN. THE PATIENT HAD SEPTIC SHOCK AND FEVER OF 39.2 °C. PERINEAL EXAMINATION SHOWED EXTENSIVE SUBCUTANEOUS NECROSIS OF THE SCROTUM AND INGUINAL AREA WITH CREPITUS ON PALPATION. CT SHOWED A LEAKAGE FROM THE STAPLE LINE WITH EXTENSIVE GAS DEVELOPING THE RECTUM, BLADDER, AND SCROTUM. THE PATIENT UNDERWENT EMERGENCY SURGERY. THE RECTUM WAS INFLATED WITH WATER AND POVIDONE-IODINE. DEBRIDEMENT AND AN END-COLOSTOMY WERE PERFORMED. REPEAT NECROSECTOMY AND HYPERBARIC OXYGEN THERAPY WERE DONE DURING THE STAY. CULTURE OF THE NECROTIC TISSUE SHOWED A POLYMICROBIAL INFECTION (ESCHERICHIA COLI, BACTEROIDES FRAGILIS, AND ENTEROCOCCI). THE WOUND HEALED COMPLETELY BY 3 MONTHS. THE PATIENT PRESENTED WITH ANAL STENOSIS THAT REQUIRED TWO DILATIONS. IT WAS REPORTED THAT THE PERFORATION MAY HAVE BEEN A DELAYED ISCHEMIC PHENOMENON, RELATED TO CRUSHING OF THE RECTAL WALL BY CLOSURE OF THE GUN BEFORE FINAL STAPLING. USUALLY THE INFECTION IS POLYMICROBIAL, FREQUENTLY WITH GAS-FORMING ORGANISMS. IT IS POSSIBLE THAT THE FIRING OF THE STAPLER ENABLED GAS-PRODUCING ORGANISMS IN THE RECTAL LUMEN TO ENTER THE PARARECTAL SPACE. CARE MUST BE TAKEN TO AVOID INCORPORATING MORE PROXIMAL PROLAPSING RECTAL MUCOSA INTO THE JAWS OF THE CLOSING GUN. PATIENTS WITH ANORECEPTIVE SEXUAL PRACTICES REQUIRE APPROPRIATE ADVICE. IT IS DEBATABLE WHETHER ANORECEPTIVE SEXUAL PRACTICE IS A CONTRAINDICATION TO STAPLED HEMORRHOIDECTOMY. INDIVIDUALS SHOULD BE WARNED THAT THE PRESENCE OF A CIRCUMFERENTIAL STAPLE LINE AT THE ANORECTAL JUNCTION MAY MAKE ANAL INTERCOURSE INTOLERABLE FOR BOTH PARTIES. THE ¿GO AHEAD¿ FOR ANAL SEX SHOULD BE GIVEN ONLY AFTER RECTAL DIGITATION BY THE SURGEON HAS CONFIRMED THAT THE STAPLE LINE IS CORRECTLY HEALED. ALTHOUGH THIS COMPLICATION IS EXCEPTIONAL, IT MUST BE INCLUDED IN CONSENT INFORMATION GIVEN TO PATIENTS WHO ARE TREATED FOR HEMORRHOID SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634761 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention