BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 22363418 · Received June 30, 2025

    Report

    Report Number
    3005075853-2025-04867
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    July 11, 2019
    Report Date
    June 30, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) 6/30/2025 THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. D4: BATCH # UNK. B3: UNKNOWN; CAPTURED AS AWARENESS DATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: STAPLED TRANSANAL RECTAL RESECTION UNDER LAPAROSCOPIC SURVEILLANCE FOR RECTOCELE AND CONCOMITANT ENTEROCELE AUTHORS: S. PETERSEN, PH.D., G. HELLMICH, M.D., A. SCHUSTER, M.D., D. LEHMANN, M.D., W. ALBERT, M.D., AND K. LUDWIG, PH.D. CITATION: DIS COLON RECTUM 2006; 49: 685¿689; DOI: 10.1007/S10350-006-0512-7; PUBLISHED ONLINE: 05 APRIL 2006. THIS STUDY DISCUSSED A COMBINED PROCEDURE OF TRANSANAL RECTAL RESECTION WITH SIMULTANEOUS LAPAROSCOPY. BETWEEN NOVEMBER 2002 AND MAY 2005, A TOTAL OF 41 PATIENTS (MALE N=3 AND FEMALE N=38, WITH MEAN AGE OF 58.1±11.3 YEARS) WERE TREATED SURGICALLY FOR ODS. FOUR OF 41 PATIENTS (MEAN AGE 55.0±11.0 YEARS) REVEALED ADDITIONAL ENTEROCELE IN THE DEFINED DIAGNOSIS PROGRAM. THESE FOUR PATIENTS UNDERWENT STARR UNDER LAPAROSCOPIC SURVEILLANCE. THE TECHNIQUE FOR STAPLING THE ANTERIOR RECTAL WALL WAS AS FOLLOWS: ACCORDING TO THE SURGEON¿S ASSESSMENT, TWO TO FOUR SEPARATED ONE-HALF PURSESTRING SUTURES (2¿0 PROLENE, ETHICON, NORDERSTEDT, GERMANY) WERE INSERTED 1¿2 CM ABOVE THE HEMORRHOIDAL PLEXUS. USING A 33-MM STAPLING DEVICE (PPH-01), THE PURSESTRING SUTURES WERE ADAPTED TO THE STAPLER AND THE STAPLER WAS FIRED. AFTER REMOVING THE STAPLING DEVICE, ADDITIONAL STITCHES FOR HEMOSTASIS WERE PLACED REGULARLY AT THE STAPLED RING USING MONOFILAMENT RESORBABLE STITCHES (4¿0 MONOCRYL, ETHICON). THE PROCEDURE WAS REPEATED ON THE POSTERIOR WALL OF THE RECTUM. COMPLICATIONS INCLUDED BLEEDING IN THE STAPLE LINE (N=2) AND LATE ABSCESS IN THE STAPLE LINE (N=1). IN CONCLUSION, THE COMBINATION OF THE STAPLED TRANSANAL RECTAL RESECTION PROCEDURE AND LAPAROSCOPY PROVIDES THE OPPORTUNITY TO PERFORM TRANSANAL RECTAL RESECTION WITHOUT THE THREAT OF INTRA-ABDOMINAL LESIONS CAUSED BY ENTEROCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2484045 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention