BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7748033 · Received August 3, 2018

    Report

    Report Number
    3005075853-2018-11851
    Event Type
    Injury
    Date Received
    August 3, 2018
    Report Date
    July 10, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036002878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONLY PUBLICATION YEAR (2010) IS KNOWN. 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 ENTITLED: FUNCTIONAL OUTCOME AND QUALITY OF LIFE AFTER STAPLED TRANSANAL RECTAL RESECTION FOR OBSTRUCTED DEFECATION SYNDROME. AUTHOR : KATJA WOLFF, M.D. ¿ LUKAS MARTI, M.D. ¿ ULRICH BEUTNER, PH.D. THOMAS STEFFEN, M.D. ¿ JOCHEN LANGE, M.D. ¿ FRANC H. HETZER, M.D. CITATION: DIS COLON RECTUM 2010; 53: 881¿888; DOI: 10.1007/DCR.0B013E3181CDB445. THE STUDY AIMED TO DETERMINE FUNCTIONAL OUTCOME AND QUALITY OF LIFE AFTER STAPLED TRANSANAL RECTAL RESECTION (STARR) FOR OBSTRUCTED DEFECATION SYNDROME (ODS). BETWEEN JAN2007 AND NOV2008, 52 FEMALE PATIENTS (MEDIAN AGE OF 64 YEARS [20-87 YEARS]) WITH ODS UNDERWENT TRANSTAR PROCEDURE. CONTOUR TRANSTAR-STR5G STAPLER WAS USED TO COMPLETE THE TRANSTAR PROCEDURE. INTRAOPERATIVE COMPLICATIONS INCLUDED ONE PATIENT WHO HAD STAPLE LINE DEHISCENCE FIXED WITH ADDITIONAL SUTURES AND RECOVERED WITHOUT ANY SEQUALAE. AT POSTOPERATIVE 5 WEEKS, ONE PATIENT DEVELOPED PERIANAL VENOUS THROMBOSIS WHICH REQUIRED INCISION UNDER LOCAL ANESTHESIA. AT 6-WEEK FOLLOW-UP, 2 PATIENTS HAD SELF-LIMITING RECTAL BLEEDING FOR WHICH ONE PATIENT PERSISTED UNTIL THE 3 MONTH FOLLOW-UP. ADDITIONALLY, 2 PATIENTS HAD PERSISTING PAIN CAUSED BY 2 RESIDUAL STAPLES TREATED BY REMOVAL OF STAPLES WITHOUT THE NEED OF ANESTHESIA AND PATIENTS RECOVERED COMPLETELY. FECAL URGENCY IS A COMMON POSTOPERATIVE FINDING OF THE PROCEDURE WHICH OCCURRED AFTER LOW ANTERIOR RESECTION FOR RECTAL CANCER AND IN MOST CASES LASTED FOR APPROXIMATELY 6 TO 12 MONTHS; REDUCTION IN RECTAL VOLUME AND DIFFERENT SENSIBILITY ARE ONE EXPLANATION. FECAL INCONTINENCE CAN BE A TYPICAL SYMPTOM OF ODS. IN CASES WHERE PATIENTS BECAME INCONTINENT AFTER THE TRANSTAR PROCEDURE, THE AUTHOR ASSUME A PRE-EXISTING ASYMPTOMATIC INCONTINENCE THAT APPEARED AFTER ANATOMIC RESTORATION. THE TRANSTAR PROCEDURE IS AN EFFECTIVE AND SAFE PROCEDURE FOR A SELECT GROUP OF PATIENTS WITH SEVERE ODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590734 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention