BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8830846 · Received July 26, 2019

    Report

    Report Number
    3005075853-2019-20788
    Event Type
    Injury
    Date Received
    July 26, 2019
    Date of Event
    January 1, 2007
    Report Date
    July 2, 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 2007. 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: STAPLED HEMORRHOIDOPEXY: A PROSPECTIVE STUDY FROM PATHOLOGY TO CLINICAL OUTCOME AUTHORS: PIERPAOLO SILERI, VITO MARIA STOLFI, GIAMPIERO PALMIERI, ALESSANDRA MELE, ALESSANDRO FALCHETTI, SARA DI CARLO, ACHILLE LUCIO GASPARI CITATION: J GASTROINTEST SURG (2007) 11:1662¿1668. DOI: 10.1007/S11605-007-0328-3. THE AUTHORS REPORT THEIR EXPERIENCE WITH THE TECHNIQUE AND CORRELATE PATHOLOGICAL FINDINGS TO SHORT- AND LONG-TERM CLINICAL OUTCOMES. BETWEEN JANUARY 2003 AND APRIL 2007, 94 SYMPTOMATIC PATIENTS (56 MALE AND 38 FEMALE; AGE RANGE: 21-75 YEARS) UNDERWENT HEMORRHOIDOPEXY IN A DAY-SURGERY SETTING. THE PROCEDURE WAS PERFORMED USING THE PPH01 KIT (ETHICON). REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE FEVER (>38°C) (N-5), POSTOPERATIVE PAIN AT 1 WEEK (N-48), POSTOPERATIVE PAIN AT 1 MONTH (N-20), POSTOPERATIVE PAIN AT 3 MONTHS (N-11), POSTOPERATIVE PAIN AT 1 YEAR (N-3), BLEEDING AT 1 WEEK (N-26) AND BLEEDING AT 1 MONTH (N-9) IN WHICH 3 PATIENTS WERE ADMITTED, AND A FOLEY CATHETER WAS INSERTED INTO THE ANORECTAL CANAL TO COMPRESS THE BLEEDING VESSELS AND 1 PATIENT FURTHER REQUIRED SURGICAL REVISION, BLEEDING AT 3 MONTHS (N-7), SOILING AT 1 WEEK (N-23), SOILING AT 1 MONTH (N-4), URGENCY AT 1 WEEK (N-12), URGENCY AT 1 MONTH (N-13), URGENCY AT 3 MONTHS (N-3), TRANSITORY FLATUS INCONTINENCE (N-2), TENESMUS (3), FISSURE (N-6) WHICH WERE INITIALLY TREATED MEDICALLY BUT 2 PATIENTS FURTHER UNDERWENT LATERAL INTERNAL SPHINCTEROTOMY, SEVERE CHRONIC PAIN (N-3) WHICH WERE TREATED MEDICALLY WITH CALCIUM CHANNEL BLOCKER OINTMENT AND 1 PATIENT FURTHER REQUIRED ANORECTAL EXPLORATION UNDER ANESTHESIA AND REMOVAL OF RETAINED STAPLES COMPLETELY RESOLVED THE PAIN, MILD INTERNAL ANAL SPHINCTER HYPERTONIA (N-1), SYMPTOMATIC ANORECTAL STENOSIS WITH URGENCY AND FREQUENCY (N-2) WHICH RESPONDED TO ANAL DILATATION WITH ANAL DILATORS, HEMORRHOIDAL RECURRENCE (N-7) IN WHICH 4 PATIENTS UNDERWENT FURTHER CONVENTIONAL HEMORRHOIDECTOMY (TWO CLOSED AND TWO OPEN EXCISION), HEMORRHOIDAL THROMBOSIS (N-1) WHICH WAS TREATED MEDICALLY, AND SKIN TAG (N-14). IN CONCLUSION, STAPLED HEMORRHOIDOPEXY IS FEASIBLE AND SAFE WHEN PERFORMED AS A DAY-SURGERY PROCEDURE FOR THIRD-DEGREE HEMORRHOIDS. BECAUSE OF THE POTENTIAL FOR SPECIFIC TECHNIQUE-RELATED COMPLICATIONS, IT SHOULD NOT BE USED FOR SECOND-DEGREE HEMORRHOIDS, WHEREAS FOR FOURTH DEGREE HEMORRHOIDS, CONVENTIONAL EXCISION MIGHT BE MORE EFFECTIVE, REDUCING THE INCIDENCE OF LONGER-TERM RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626656 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention