BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8786317 · Received July 12, 2019

    Report

    Report Number
    3005075853-2019-20371
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    January 1, 2007
    Report Date
    June 18, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2007. MEDICAL DEVICE: 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 HEMORROIDOPEXY: DAY SURGERY OR ONE DAY SURGERY? AUTHOR: D.P. GRECO,_, G. MIOTTI, A. DELLA VOLPE, C. MAGISTRO, S. DE CARLI, R. PUGLIESE. CITATION: SURGICAL ONCOLOGY (2007) 16, S173¿S175 / DOI:10.1016/J.SURONC.2007.10.041. THE PURPOSE OF THIS SYSTEMATIC REVIEW WAS TO EVALUATE IF STAPLE HEMORRHOIDOPEXY CAN BE DONE AS DAY SURGERY OR ONE DAY SURGERY. SINCE 2005, OUT OF 327 PATIENT, 91 PATIENTS UNDERWENT HEMORRHOIDOPEXY WITH THE USE OF CIRCULAR STAPLER 33 (PPH03). COMPLICATION INCLUDED POST-SURGERY BLEEDING (N=1) THAT REQUIRED RE-HOSPITALIZATION WITH ANOSCOPY AND PLUGGING, BUT NO TRANSFUSION. THE EXPERIENCE SO FAR CARRIED OUT HAD ALREADY SHOWN US THAT ONE DAY SURGERY WAS NOT ADEQUATE TO PROTECT AGAINST BLEEDING EPISODES THAT MAY HAVE EVEN A LATE ONSET. THE NEW PROTOCOL WHICH INCLUDES THE USE OF FLOSEAL, AND A CAREFUL POST-SURGERY CONTROL WITH LOCAL MEASUREMENTS AND SURVEILLANCE WITH FOLEY PROVIDE ALL THE USEFUL GUARANTEES FOR AN EARLY AND SAFE DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578238 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention