BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

    MDR report key: 20482351 · Received October 18, 2024

    Report

    Report Number
    3005075853-2024-07867
    Event Type
    Injury
    Date Received
    October 18, 2024
    Date of Event
    December 29, 2023
    Report Date
    October 28, 2024
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/18/2024. D4: BATCH # UNK. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, 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. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/28/2024. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THANKS FOR YOUR EMAIL REGARDING MY LITERATURE ARTICLE TITLED "COMPARISON BETWEEN STAPLED HEMORRHOIDOPEXY AND HARMONIC SCALPEL HEMORRHOIDECTOMY IN THE MANAGEMENT OF THIRD- AND FOURTH-DEGREE PILES: A RANDOMIZED CLINICAL TRIAL" THANK YOU FOR YOUR FOLLOW-UP REGARDING THE QUALITY OF YOUR PRODUCTS AND FOR INQUIRING ABOUT MY RECENT ARTICLE. I APPRECIATE YOUR COMMITMENT TO MAINTAINING HIGH STANDARDS AND FOSTERING OPEN COMMUNICATION. AS MENTIONED, WHILE THE STAPLER ITSELF IS NOT DIRECTLY ASSOCIATED WITH COMPLICATIONS DUE TO ITS BRAND, WE HAVE OBSERVED TECHNIQUE-RELATED ISSUES SUCH AS POST-OPERATIVE PAIN, CONGESTION, AND FISTULA FORMATION. THESE CONCERNS HAVE LED US TO REDUCE THE USE OF THE STAPLER TECHNIQUE IN OUR PRACTICE. INSTEAD, WE ARE NOW USING THE HARMONIC DEVICE (ETHICON) MORE FREQUENTLY IN THE MILLIGAN-MORGAN TECHNIQUE, WHICH WE FIND PROVIDES IMPROVED OUTCOMES FOR OUR PATIENTS. THANK YOU ONCE AGAIN FOR YOUR CONTINUED SUPPORT AND ATTENTION. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    TITLE: COMPARISON BETWEEN STAPLED HEMORRHOIDOPEXY AND HARMONIC SCALPEL HEMORRHOIDECTOMY IN THE MANAGEMENT OF THIRD- AND FOURTH-DEGREE PILES: A RANDOMIZED CLINICAL TRIAL. AUTHORS: MOHAMED ALI MOHAMED NADA, PHILOBATER BAHGAT ADLY AWAD, ANDREW MORCOS AZMY KIROLLOS, MOSTAFA MOHAMED ABDELAZIZ, KARIM MOHAMED SAAD MOHAMED, KEROLOS BAHGAT ADLY AWAD, BASMA HUSSEIN ABDELAZIZ HASSAN. CITATION: CHIRURGIE. HTTPS://DOI.ORG/10.1007/S00104-023-02010-9. THE AIM OF THIS STUDY WAS TO COMPARE THE RESULTS OF STAPLED HEMORRHOIDOPEXY (SH) AND HARMONIC SCALPEL HEMORRHOIDECTOMY (HSH) IN THE MANAGEMENT OF GRADE III AND GRADE IV PILES REGARDING THE TIME OF THE PROCEDURE, POSTOPERATIVE PAIN, PATIENT SATISFACTION, WOUND INFECTION, BLEEDING, INCONTINENCE, AND RECURRENCE WITHIN 1 YEAR. THIS WAS A SINGLE-BLIND, PROSPECTIVE, RANDOMIZED, CONTROLLED, SINGLE-CENTER TRIAL CONDUCTED FROM JANUARY TO DECEMBER 2022 THAT INCLUDED A TOTAL OF 70 PATIENTS (50 MALE AND 20 FEMALE) WITH THIRD- AND FOURTH-DEGREE PILES. THE PATIENTS WERE DIVIDED INTO TWO GROUPS OF 35 PATIENTS EACH. GROUP I UNDERWENT SH AND GROUP II UNDERWENT HSH. THE MEAN AGE OF GROUP I WAS 42.94 YEARS AND OF GROUP II, 42.20 YEARS. GROUP I UNDERWENT STAPLER HEMORRHOIDECTOMY USING THE EXTERNAL DEVICE (TRANSPARENTANOSCOPE) OF A PPH STAPLER (PROXIMATE PPH HEMORRHOIDAL CIRCULAR STAPLER SET; ETHICON INC., RARITAN, NEW JERSEY, USA). HEMOSTASIS ALONG THE STAPLE LINE WAS ACHIEVED, AND IF REQUIRED, A 3-0 VICRYL SUTURE WAS USED IN THE CASE OF BLEEDING. IN GROUP II, THE PROCEDURE WAS PERFORMED USING THE HARMONIC BLADES (ETHICON ENDO-SURGERY INC., CINCINNATI, OH, USA). REPORTED COMPLICATIONS IN GROUP I INCLUDE PAIN (MILD AND MODERATE) AT FIRST 2 WEEKS AND AFTER 2 WEEKS, WOUND INFECTION, POSTOPERATIVE BLEEDING, AND RECURRENCE. IN GROUP II INCLUDE PAIN (MILD, MODERATE, AND SEVERE) AT FIRST 2 WEEKS, PAIN (MILD AND MODERATE) AFTER 2 WEEKS, AND RECURRENCE. IN CONCLUSION, COMPARED WITH SH, HSH WAS SAFER, EASIER, AND ASSOCIATED WITH A LOWER INCIDENCE OF RECURRENCE AFTER 1 YEAR AND WITH HIGHER PATIENT SATISFACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991573 PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention