BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 17072890 · Received June 6, 2023

    Report

    Report Number
    3005075853-2023-03833
    Event Type
    Injury
    Date Received
    June 6, 2023
    Date of Event
    March 10, 2023
    Report Date
    June 6, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE 6/6/2023 D4: BATCH # UNK 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. 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: PERIRECTAL HEMATOMA AFTER STAPLED SURGERY FOR HEMORRHOIDAL PROLAPSE AND OBSTRUCTED DEFECATION SYNDROME: CASE SERIES MANAGEMENT TO AVOID PANIC-GUIDED TREATMENT. AUTHORS: DOMENICO MASCAGNI, CHIARA EBERSPACHER, GABRIELE NALDINI, FRANCESCO LEONE ARCIERI, PIETRO MASCAGNI, ROBERTO CIROCCHI, GEORGI POPIVANOV, PIERPAOLO SILERI, STEFANO ARCIERI. CITATION: UPDATES IN SURGERY (2023) 75:627¿634 HTTPS://DOI.ORG/10.1007/S13304-023-01490-Y. THE AIM OF THIS STUDY IS TO ANALYZE A HOMOGENOUS CASE SERIES OF PH AND TO DEFINE A TREATMENT ALGORITHM FOR HUGE POSTOPERATIVE PHS. A RETROSPECTIVE ANALYSIS OF A PROSPECTIVE DATABASE OF THREE HIGH-VOLUME PROCTOLOGY UNITS WAS PERFORMED BETWEEN 2008 AND 2018, AND ALL PH CASES WERE ANALYZED. IN ALL, 3058 PATIENTS UNDERWENT STAPLING PROCEDURES FOR HEMORRHOIDAL DISEASE OR OBSTRUCTED DEFECATION SYNDROME WITH INTERNAL PROLAPSE. AMONG THESE, 14 LARGE PH CASES WERE REPORTED. ALL 14 PATIENTS WERE FEMALE, AGED 41¿70 YEARS. DIFFERENT TYPES OF STAPLERS AND SURGICAL TECHNIQUES WERE USED: TWO PATIENTS UNDERWENT HEMORRHOIDOPEXY (ONE WITH PPH01, ONE WITH PPH03), FIVE UNDERWENT STARR WITH TWO STAPLERS (TWO PPH01 IN THREE CASES AND TWO PPH03 IN TWO CASES), AND SEVEN UNDERWENT STARR WITH ONE HIGH-VOLUME STAPLER. REPORTED COMPLICATIONS INCLUDED PERIRECTAL HEMATOMA RECURRENCE (N=7), ABDOMINAL TENDERNESS (N=6), SUDDEN HYPOTENSION (N=2), BLEEDING (N=2), ANAL BLEEDING (N=2) AND ANASTOMOTIC LEAKAGE (N=2). PPH01: PATIENT #2, FEMALE, 50 YEARS OLD, POSTOP BLEEDING , ANAL PAIN AND PERITONISM; TREATMENT: HEMOSTASIS WAS PERFORMED FOR BLEEDING. PPH03: PATIENT #3, FEMALE, 56 YEARS OLD,  ANAL PAIN; TREATMENT: NOT REPORTED. PPH01: PATIENT #6, FEMALE, 55 YEARS OLD, ANAL PAIN AND FEVER; TREATMENT: NOT REPORTED. PPH01: PATIENT #7, FEMALE, 41 YEARS OLD, ANAL PAIN, PERITONISM; TREATMENT: NOT REPORTED. PPH01: PATIENT #10 ,FEMALE, 42 YEARS OLD, ANAL PAIN; TREATMENT: NOT REPORTED. PPH03: PATIENT #11, FEMALE, 56 YEARS OLD, BLEEDING AND ANAL PAIN; TREATMENT: HEMOSTASIS WAS PERFORMED FOR BLEEDING. PPH03: PATIENT #12, FEMALE, 70 YEARS OLD, BLEEDING AND ANAL PAIN; TREATMENT: NOT REPORTED. IN CONCLUSION PATIENTS WITH HEMODYNAMICALLY STABLE PH CAN BE TREATED SAFELY AND EFFECTIVELY WITHOUT A SURGICAL APPROACH. THESE PATIENTS NEED TO BE MONITORED USING CLINICAL PARAMETERS, CT AND BLOOD COUNT EVALUATIONS AND TREATED WITH MEDICAL THERAPY AND ANTIBIOTICS TO PREVENT SEPTIC COMPLICATIONS. MOST PHS ARE STABLE AND EVOLVE WITH SPONTANEOUS DRAINAGE OR REABSORPTION. IN RARE CASES OF PROGRESSIVE PH, ANGIOGRAPHY WITH EMBOLIZATION IS CRUCIAL TO AVOID MAJOR SURGERY AND THE ASSOCIATED SEVERE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675967 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PPH01 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention