BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

    MDR report key: 8841311 · Received July 30, 2019

    Report

    Report Number
    3005075853-2019-20879
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    January 1, 2009
    Report Date
    July 10, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    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: IS SIMPLE MUCOSAL RESECTION REALLY POSSIBLE? CONSIDERATIONS ABOUT HISTOLOGICAL FINDINGS AFTER STAPLED HEMORRHOIDOPEXY. AUTHOR : GABRIELE NALDINI & JACOPO MARTELLUCCI & LUCA MORALDI & NICOLA ROMANO & MAURO ROSSI. CITATION: INT J COLORECTAL DIS. 2009; 24: 537¿541. DOI: 10.1007/S00384-009-0636-Z. THE COMMON REMOVAL OF SMOOTH MUSCLE DURING STAPLED HEMORRHOIDECTOMY HAD RAISED CONCERNS ABOUT ITS EFFECTS ON POSTOPERATIVE ANORECTAL FUNCTION. THE PURPOSE OF THE STUDY IS TO CONFIRM THE HIGH FREQUENCY OF THE INVOLVEMENT OF SMOOTH MUSCLE FIBERS IN STAPLED HEMORRHOIDECTOMY AND TO DETERMINE ITS ASSOCIATION WITH POSTOPERATIVE FINDINGS. THIS RETROSPECTIVE STUDY EVALUATED 241 CASES (168 MALE AND 73 FEMALE PATIENTS; AGE RANGE: 22 TO 75 YEARS OLD) OF STAPLED HEMORRHOIDOPEXY TREATED FROM 2003 TO 2006. DURING THE SURGICAL PROCEDURE, A PPH01 OR PPH03 33-MM CIRCULAR STAPLER (ETHICON) WAS USED FOR ALL THE PROCEDURES. REPORTED COMPLICATIONS INCLUDED BLEEDING (N-14) WHICH REQUIRED REINTERVENTION FOR HEMOSTASIS IN 8 PATIENTS, ANAL PAIN (N-8) IN WHICH THE PAIN WAS TREATED WITH ORAL ANALGESIC AND LOCAL NITROGLYCERINE OINTMENTS, FLATUS INCONTINENCE (N-2), ABSCESS (N-2), HEMATOMA (N-1), AND RECURRENCE (N-11). THE PRESENCE OF SMOOTH MUSCLE FIBERS IN THE HISTOLOGICAL SPECIMENS DOES NOT SEEM TO INFLUENCE THE STAPLED HEMORRHOIDOPEXY OUTCOME REGARDING PAIN, BLEEDING, CONTINENCE, RECURRENCE, OR PATIENTS¿ SATISFACTION. MOREOVER, THE ANATOMICAL STRUCTURE OF THE ANAL REGION HAS ELEMENTS THAT KEEP THE MUCOSA AND THE SUBMUCOSA LINKED TO THE MUSCLE. IT IS CLEAR THAT THE SMOOTH MUSCLE PRESENCE IN THE RESECTED TISSUE IS NOT A TECHNICAL ERROR, BUT A COMMON FEATURE MAYBE CONNECTED TO A GOOD RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635928 PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention