BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 9270609 · Received November 3, 2019

    Report

    Report Number
    3005075853-2019-23198
    Event Type
    Injury
    Date Received
    November 3, 2019
    Date of Event
    January 1, 2005
    Report Date
    October 11, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2005. MEDICAL DEVICE: BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: STAPLED HEMORRHOIDOPEXY VS. HARMONIC SCALPEL¿ HEMORRHOIDECTOMY: A RANDOMIZED TRIAL. AUTHOR/S: C. C. CHUNG, F.R.C.S.(EDINB.), HESTER Y. S. CHEUNG, M.R.C.S.(EDINB.), EVA S. W. CHAN, F.R.C.S.(EDINB.), S. Y. KWOK, F.R.C.S.(EDINB.), F.R.A.C.S., MICHAEL K. W. LI, F.R.C.S.(EDINB.), F.R.C.S.(ENGL.) CITATION: DIS COLON RECTUM. 2005; 48: 1213¿1219. DOI: 10.1007/S10350-004-0918-Z. A RANDOMIZED TRIAL WAS UNDERTAKEN TO EVALUATE AND COMPARE STAPLED HEMORRHOIDOPEXY WITH EXCISIONAL HEMORRHOIDECTOMY IN WHICH THE HARMONIC SCALPEL (ETHICON) WAS USED. A TOTAL OF 88 PATIENTS WITH GRADE III HEMORRHOIDS WHO WERE EMPLOYED DURING THE TRIAL PERIOD WERE RECRUITED AND RANDOMIZED INTO TWO GROUPS, THE HARMONIC SCALPEL (ETHICON) HEMORRHOIDECTOMY (AGE: 44 YEARS; 30 MALE AND 15 FEMALE PATIENTS) AND STAPLED HEMORRHOIDOPEXY (AGE: 47.4 YEARS; 29 MALE AND 14 FEMALE PATIENTS). IN THE HARMONIC SCALPEL HEMORRHOIDECTOMY GROUP, DISSECTION, INCLUDING SKIN INCISION, AND HEMOSTASIS WERE ALL PERFORMED WITH THE HARMONIC SCALPEL (ETHICON), THE POWER OF WHICH WAS SET AT LEVEL THREE. IN THE STAPLED HEMORRHOIDOPEXY GROUP, THE AUTHORS USED PPH 33 CIRCULAR STAPLER (ETHICON). IN THE HARMONIC SCALPEL HEMORRHOIDECTOMY GROUP, REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE HEMORRHAGE (N-2), ONE OF THEM REQUIRING SUTURE PLICATION IN THE OPERATING ROOM. IN THE STAPLED HEMORRHOIDOPEXY GROUP, REPORTED COMPLICATIONS INCLUDED REACTIONARY HEMORRHAGE (N-1) NECESSITATING REOPERATION. THE PRESENT REPORT HAS SHOWN THAT STAPLED HEMORRHOIDOPEXY IS A SAFE AND EFFECTIVE PROCEDURE FOR PATIENTS SUFFERING FROM GRADE III HEMORRHOIDAL DISEASE. PATIENTS UNDERGOING THE STAPLED PROCEDURE DERIVE GREATER SHORT-TERM BENEFITS, WITH REDUCED PAIN, SHORTER LENGTH OF HOSPITAL STAY, AND EARLIER RETURN TO WORK. THESE BENEFITS ARE ALSO IMPORTANT TO HOSPITAL ADMINISTRATORS AND SHOULD BE BORNE IN MIND WHEN PLANNING HEALTH CARE SERVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064911 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention