BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

    MDR report key: 8860249 · Received August 5, 2019

    Report

    Report Number
    3005075853-2019-21051
    Event Type
    Injury
    Date Received
    August 5, 2019
    Date of Event
    January 1, 2006
    Report Date
    July 12, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: HEMORRHOIDOPEXY STAPLE LINE HEIGHT PREDICTS RETURN TO WORK AUTHOR : MARGARET D. PLOCEK, M.D., LAURIE ANN KONDYLIS, R.N., B.S., NADINE DUHAN-FLOYD, M.D., JOHN C. REILLY, M.D., DANIEL P. GEISLER, M.D., PHILIP D. KONDYLIS, M.D. CITATION: DIS COLON RECTUM 2006; 49: 1905¿1909; DOI: 10.1007/S10350-006-0724-X; PUBLISHED ONLINE: 13 OCTOBER 2006. THE PURPOSE OF THIS STUDY WAS TO FURTHER INVESTIGATE AND REFINE THE ROLE OF STAPLE HEIGHT IN THE PREDICTION OF POSTOPERATIVE OUTCOMES. FROM JULY 2002 TO OCTOBER 2004, 75 PATIENTS WITH A MEDIAN AGE OF 49 YEARS (RANGE, 25-87) (MALE N=46, FEMALE N=29) WITH SYMPTOMATIC GRADE 3 AND 4 MIXED HEMORRHOIDS UNDERWENT STAPLED HEMORRHOIDOPEXY. A 33-MM PROXIMATE HCS HEMORRHOIDAL CIRCULAR STAPLER (ETHICON ENDO-SURGERY, INC. CINCINNATI, OH) WAS USED FOR ALL PROCEDURES. THE OPEN STAPLER WAS PASSED THROUGH THE PURSESTRING WHERE IT WAS THEN SECURED. THE STAPLER WAS HELD IN THE CLOSED POSITION FOR 45 SECONDS BEFORE FIRING. COMPLICATIONS INCLUDED PAIN (N=3) WHICH REQUIRED READMISSIONS FOR PAIN CONTROL, ACUTE POSTOPERATIVE ANAL FISSURES (N=3), POSTOPERATIVE BLEEDS (N=2) (WITH ONE REQUIRING EXAMINATION UNDER ANESTHESIA WITHOUT INTERVENTION), SELF-LIMITED CASE OF SUBCUTANEOUS EMPHYSEMA (N=1), FECAL IMPACTION (N=1) WHICH REQUIRED ADMISSION, POSTOPERATIVE SEEPAGE (N=1) AND RECURRENCE OF INTERNAL HEMORRHOIDAL PROLAPSE (N=3). IN CONCLUSION, A HEMORRHOIDOPEXY STAPLE LINE =22 MM ABOVE THE DENTATE LINE CORRELATES WITH A SIGNIFICANTLY SHORTER NEED FOR POSTOPERATIVE NARCOTICS (P = 0.024) AND AN EARLIER RETURN TO WORK (P = 0.017). STAPLE LINE DISTANCE ABOVE THE DENTATE LINE MEANINGFULLY IMPACTS COMFORT-BASED OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654664 PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R