BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*PPH PROCEDURE SET

    MDR report key: 8817729 · Received July 23, 2019

    Report

    Report Number
    3005075853-2019-20676
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 26, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036013006
    PMA / PMN Number
    K051301
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2010. 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: PPH03 STAPLED HEMORRHOIDECTOMY: OUR EXPERIENCE. AUTHOR : Y.K. LIM ¿ K.W. EU ¿ K.S. HO ¿ B.S. OOI ¿ C.L. TANG . CITATION: TECH COLOPROCTOL. 2006; 10: 43¿46. DOI: 10.1007/S10151-006-0249-3. STAPLED HEMORRHOIDECTOMY IS AN ESTABLISHED TREATMENT FOR HEMORRHOIDAL DISEASE. THE AUTHORS EVALUATED THE EXPERIENCE WITH STAPLED HEMORRHOIDECTOMY USING THE NEW PROXIMATE PPH03 HCS HEMORRHOIDAL CIRCULAR STAPLER (ETHICON). THE AUTHORS RETROSPECTIVELY REVIEWED CLINICAL DATA FOR 238 PATIENTS (AGE RANGE: 17 TO 91 YEARS OLD; 115 MALE AND 123 FEMALE PATIENTS) WHO HAD UNDERGONE STAPLED HEMORRHOIDECTOMY IN THE INSTITUTION. REPORTED COMPLICATIONS INCLUDED PAIN (N-5) WHICH REQUIRED ADMISSION AND TREATED CONSERVATIVELY, SECONDARY HEMORRHAGE (N-12) WHICH REQUIRED READMISSION, EXAMINATION UNDER ANESTHESIA, AND HEMOSTASIS IN 4 CASES; 5 CASES REQUIRED BLOOD TRANSFUSION, STENOSIS (N-1) WHICH REQUIRED READMISSION AND ANOPLASTY, ANAL FISSURE (N-1) WHICH REQUIRED LATERAL SPHINCTEROTOMY, MILD PAIN (N-18), SLIGHT STAINING OR BLEEDING (N-16), SKIN TAGS (N-15), SLIGHT DIFFICULTY IN EVACUATION (N-11), PRURITUS (N-5), MUCOUS DISCHARGE (N-3), RESIDUAL SKIN TAGS (N-3), ANAL DISCOMFORT (N-2), SLIGHT BLOODSTAINING (N-3), AND MILD ANAL STRICTURE (N-2) WHICH WAS MANAGED SATISFACTORILY WITH FINGER DILATATION. IN CONCLUSION, STAPLED HEMORRHOIDECTOMY USING THE NEW PPH03 STAPLER IS A RELATIVELY SAFE AND SHORT PROCEDURE FOR THE MANAGEMENT OF HEMORRHOIDS AND CAN BE DONE IN THE AMBULATORY SETTING WITH SATISFACTORY SHORT-TERM RESULTS. IT IS A MODIFICATION OF THE PREVIOUS PPH01 STAPLER WITH A LOW RATE OF IMMEDIATE POSTOPERATIVE COMPLICATIONS, ALTHOUGH LONG-TERM RESULTS ARE STILL AWAITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609083 PROXIMATE*PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036013006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention