BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 9534989 · Received December 31, 2019

    Report

    Report Number
    3005075853-2019-24842
    Event Type
    Injury
    Date Received
    December 31, 2019
    Date of Event
    January 1, 2003
    Report Date
    December 9, 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
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2003. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY 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: DAY-CASE STAPLED (CIRCULAR) VS. DIATHERMY HEMORRHOIDECTOMY, A RANDOMIZED, CONTROLLED TRIAL EVALUATING SURGICAL AND FUNCTIONAL OUTCOME. AUTHOR/S: MATTI KAIRALUOMA, M.D., PH.D., YOSTI NUORVA, M.D., PH.D., ILMO KELLOKUMPU, M.D., PH.D. CITATION: DIS COLON RECTUM 2003; 46:93¿99. THE AIMED OF THIS RANDOMIZED, CONTROLLED STUDY TO COMPARE THE EFFICACY AND VALUE OF STAPLED HEMORRHOIDECTOMY WITH THAT OF DIATHERMY HEMORRHOIDECTOMY IN A DAY-CASE. BETWEEN APRIL 1999 AND AUGUST 2000, 60 PATIENTS WERE ENROLLED IN THE STUDY IN WHICH 30 PATIENTS (MALE=19, FEMALE=11; MEAN AGE=48.5 YEARS, AGE RANGE=17-65 YEARS) UNDERWENT DIATHERMY HEMORRHOIDECTOMY AND 30 PATIENTS (MALE=13, FEMALE=17; MEAN AGE=47 YEARS, AGE RANGE=25-65 YEARS) STAPLED HEMORRHOIDECTOMY. THE PATIENTS UNDERWENT EITHER CONVENTIONAL HEMORRHOIDECTOMY WITH DIATHERMY DISSECTION AND WITHOUT PEDICLE LIGATION OR STAPLED HEMORRHOIDECTOMY BY MEANS OF THE PPH01 STAPLING DEVICE (ETHICON). REPORTED COMPLICATIONS INCLUDED MINOR SECONDARY BLEEDING FROM THE STAPLE LINE (N=2) ON DAYS 1 AND 7 AFTER SURGERY AND WAS TREATED BY ADRENALINE INJECTION; ANASTOMOTIC STENOSIS (N=1) AND WAS TREATED BY BALLOON DILATATION; TREATMENT FAILURES (N=7) WHICH NECESSITATED SUBSEQUENT TREATMENTS. IN CONCLUSION, STAPLED HEMORRHOIDECTOMY IS A SIGNIFICANTLY LESS PAINFUL OPERATION THAN DIATHERMY HEMORRHOIDECTOMY BUT DOES NOT SEEM TO OFFER SIGNIFICANT ADVANTAGES IN TERMS OF HOSPITAL STAY OR SYMPTOM CONTROL IN THE LONG TERM. HEMORRHOIDECTOMY MAY IMPROVE SYMPTOMS OF DIFFICULT RECTAL EVACUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329694 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention