BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 7735406 · Received July 31, 2018

    Report

    Report Number
    3005075853-2018-11726
    Event Type
    Injury
    Date Received
    July 31, 2018
    Report Date
    July 4, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE ENTITLED: PRIMARY AND REPEATED PERINEAL STAPLED PROLAPSE RESECTION. AUTHOR : D. RAAHAVE, A. K. JENSEN, L. DAMMEGAARD, I. K. PEDERSEN. CITATION: TECH COLOPROCTOL (2016) 20:853¿857; DOI 10.1007/S10151-016-1557-9. THE AIM OF THE PRESENT STUDY WAS TO ASSESS THE INITIAL RESULTS, COMPLICATIONS, AND RECURRENCE RATE AFTER PERINEAL STAPLED PROLAPSE RESECTION (PSPR), THE NEED FOR A SECOND PSPR, AND THE OUTCOMES AFTER A 4-YEAR FOLLOW-UP. BETWEEN 18-MAY-2009 AND 20-FEB-2015, 54 PATIENTS (N=3 MALE AND N=51 FEMALE; MEAN AGE OF 77.2 YEARS [RANGED 46-93 YEARS]) WITH FULL-THICKNESS EXTERNAL RECTAL PROLAPSE UNDERWENT PSPR. IN THE PROCEDURE, THE PROLAPSE WAS RESECTED COUNTERCLOCKWISE USING CONTOUR CURVED CUTTER STAPLER BEGINNING AT 3 O¿CLOCK AND AT 9 O¿CLOCK POSTERIORLY AND THE STAPLER WAS FIRED 3-4 TIMES. POSTOPERATIVELY, COMPLICATIONS INCLUDED BLEEDING (N=5) TREATED WITH HEMOSTASIS IN 2 PATIENTS, ANASTOMOTIC LEAK (N=1) TREATED CONSERVATIVELY, STENOSIS (N=2) TREATED WITH DILATATION AND INFECTION (N=1) TREATED CONSERVATIVELY. PSPR IS A RATHER NEW SURGICAL PROCEDURE FOR EXTERNAL RECTAL PROLAPSE. IMMEDIATE COMPLICATIONS ARE FEW AND NOT SERIOUS. ALTHOUGH RECURRENCES CAN BE TREATED WITH A SECOND PSPR, THE OPERATION MAY ONLY BE THE BEST OPTION FOR OLD AND FRAGILE PATIENTS WITH COMORBIDITIES AND A SHORT LIFE EXPECTANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578279 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention