BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8722806 · Received June 21, 2019

    Report

    Report Number
    3005075853-2019-19934
    Event Type
    Injury
    Date Received
    June 21, 2019
    Report Date
    May 29, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. WOUND INFECTION. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: UNPLANNED ADMISSION AFTER DAY-CASE HAEMORRHOIDECTOMY: A RETROSPECTIVE STUDY. AUTHOR: PIK YAN CHAN,1 MONICA PIK LIN LEE,1 HESTER YUI SHAN CHEUNG, 2 CHI CHUI CHUNG2 AND MICHAEL KA WAH LI. CITATION: ASIAN JOURNAL OF SURGERY (2010); 33:203-207. THIS STUDY AIMED TO IDENTIFY THE FACTORS ASSOCIATED WITH UNPLANNED ADMISSION FOLLOWING DAY-CASE HAEMORRHOIDECTOMY. THIS STUDY WAS A RETROSPECTIVE REVIEW OF THE OUTCOMES OF 243 PATIENTS (129 MALE AND 114 FEMALE; AGE RANGE: 22-80 YEARS) WHO UNDERWENT ELECTIVE, INTENDED DAY-CASE HAEMORRHOIDECTOMY BETWEEN JANUARY 2005 AND DECEMBER 2009. EXCISIONAL HAEMORRHOIDECTOMY WAS PERFORMED IN 167 PATIENTS; THE REMAINING 76 UNDERWENT THE STAPLED PROCEDURE. FOR PATIENTS UNDERGOING THE STAPLED PROCEDURE, A PPH 33 CIRCULAR STAPLER (ETHICON) WAS USED. REPORTED COMPLICATIONS INCLUDED POST HAEMORRHOIDECTOMY WOUND INFECTION (N-?), POST HAEMORRHOIDECTOMY BLEEDING (N-?), AND ANAL WOUND PAIN (N-?). IN CONCLUSION, GOOD OPERATION LISTING AND THE USE OF GENERAL ANAESTHESIA ARE RECOMMENDED IN THE PRACTICE OF DAY-CASE HAEMORRHOIDECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518441 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1