BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8816448 · Received July 23, 2019

    Report

    Report Number
    3005075853-2019-20664
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 26, 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
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2006. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: RECTAL STENOSIS AFTER PROCEDURES FOR PROLAPSE AND HEMORRHOIDS (PPH)¿A REPORT FROM CHINA. AUTHOR : LIQIN YAO, MD, YUNSHI ZHONG, MD, JIANMIN XU, MD, PHD, MEIDONG XU, MD, PHD, PINGHONG ZHOU, MD, PHD. CITATION: WORLD J SURG (2006) 30: 1311¿1315; DOI: 10.1007/S00268-005-0484-0; PUBLISHED ONLINE: 13 JUNE 2006. THIS RETROSPECTIVE STUDY AIMED TO EVALUATE STENOSIS OF THE LOWER RECTUM AS ONE OF THE DELAYED COMPLICATIONS FOLLOWING PPH. BETWEEN JULY 2000 AND DECEMBER 2004, 489 PATIENTS WITH MEAN AGE OF 59 YEARS (MALE N=222 AND FEMALE N=267) WHO WERE TREATED SURGICALLY WITH PPH WERE REVIEWED. TWO PURSE-STRING SUTURES WERE PLACED, AND THE PPH 33 MM ETHICON ENDOSURGERY STAPLER (PPH 01) WAS USED. COMPLICATIONS INCLUDED RECTAL STENOSIS (N=12) IN WHICH TEN PATIENTS UNDERWENT BALLOON DILATION THROUGH COLONOSCOPY, AND THE OTHER TWO PATIENTS UNDERWENT STRICTUREPLASTY WITH ELECTROCAUTERY UNDER COLONOSCOPY; AND SEVERE POSTOPERATIVE PAIN (N=35) IN WHICH PATIENTS WERE PRESCRIBED ORAL ANTIBIOTICS, AND THIS TREATMENT RELIEVED THE SYMPTOMS IN SOME CASES. IN CONCLUSION, RECTAL STENOSIS IS AN UNCOMMON EVENT AFTER PPH. EARLY STENOSIS WILL OCCUR WITHIN THE FIRST 4 MONTHS AFTER SURGERY. IN MOST CASES, THE STENOSIS CAN BE CURED THROUGH COLONOSCOPY SURGERY. PREDICTIVE FACTORS FOR STENOSIS ARE PREVIOUS SCLEROSIS THERAPY FOR HEMORRHOIDS AND SEVERE POSTOPERATIVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609410 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention