BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8840739 · Received July 30, 2019

    Report

    Report Number
    3005075853-2019-20825
    Event Type
    Injury
    Date Received
    July 30, 2019
    Date of Event
    January 1, 2005
    Report Date
    July 10, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036012993
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2005. 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: EXPERIENCE OF 3711 STAPLED HAEMORRHOIDECTOMY OPERATIONS. AUTHORS: K.-H. NG, K.-S. HO, B.-S. OOI, C.-L. TANG AND K.-W. EU. CITATION: BRITISH JOURNAL OF SURGERY (2006); 93: 226¿230. DOI: 10.1002/BJS.5214. THE AIM OF THIS STUDY WAS TO REVIEW RETROSPECTIVELY THE EFFECTIVENESS AND EFFICIENCY OF STAPLED HAEMORRHOIDECTOMY. A RETROSPECTIVE REVIEW WAS UNDERTAKEN OF ALL PATIENTS WHO UNDERWENT STAPLED HAEMORRHOIDECTOMY BETWEEN OCTOBER 1999 AND MAY 2004. A TOTAL OF 3711 PATIENTS (48.9% MALE AND 51.1% FEMALE; MEDIAN AGE: 50; AGE RANGE: 18-88 YEARS) HAD THE SURGERY. STAPLED HAEMORRHOIDECTOMY WAS PERFORMED USING A MODIFICATION OF THE LONGO TECHNIQUE, WITH A PPH01 STAPLER (ETHICON). REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N-160) IN WHICH 27 PATIENTS REQUIRED BLOOD TRANSFUSION, 66 PATIENTS HAD A SUBMUCOSAL ADRENALINE INJECTIONS BEING SUCCESSFUL IN 62 PATIENTS, 16 PATIENTS REQUIRED SURGICAL HEMOSTASIS, AND IN 81 PATIENTS, THE BLEEDING STOPPED WITHOUT INTERVENTION, SIGNIFICANT POSTOPERATIVE PAIN (N-57) IN WHICH THE PATIENTS WERE READMITTED AND WERE TREATED CONSERVATIVELY WITH ANALGESIA, ANORECTAL STRICTURE (N-52) REQUIRING INTERVENTION OF STRICTUROPLASTY OR ANAL DILATATION, ANASTOMOTIC DEHISCENCE (N-3) THAT REQUIRED REPAIR AND TEMPORARY DEFUNCTIONING COLOSTOMY, RETROPERITONEAL SEPSIS (N-1), LARGE ANTERIOR HORSESHOE ABSCESS (N-1) THAT REQUIRED FURTHER SURGERY FOR INCISION AND DRAINAGE, SEVERE PAIN SECONDARY TO PERIANAL THROMBOSIS/HEMATOMA (N-2) IN WHICH AN EVACUATION OF HEMATOMA WAS PERFORMED FOR BOTH PATIENTS, SIGNIFICANT RESIDUAL PERIANAL SKIN TAGS (N-3) IN WHICH AN EXCISION OF THESE SKIN TAGS WAS UNDERTAKEN FOR THESE PATIENTS UNDER GENERAL ANAESTHESIA, RECURRENT HEMORRHOIDAL PROLAPSE (N-11) IN WHICH THE PATIENTS HAD TO UNDERGO FURTHER HEMORRHOIDECTOMY, AND RECURRENT BLEEDING (N-1) WHICH WAS SUCCESSFULLY TREATED WITH CONSERVATIVE MEASURES. IN CONCLUSION, CONSIDERABLE EXPERIENCE OF STAPLED HAEMORRHOIDECTOMY CONFIRMS IT AS A SAFE AND EFFECTIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635002 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention