BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 7723135 · Received July 26, 2018

    Report

    Report Number
    3005075853-2018-11570
    Event Type
    Injury
    Date Received
    July 26, 2018
    Report Date
    June 29, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036002878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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: NEW KID ON THE BLOCK: PERINEAL STAPLED PROLAPSE RESECTION. (PSP) IS IT WORTHWHILE IN THE LONG-TERM?.. AUTHOR : BIANKA HUMMEL, JULIA HARDT, STEPHAN BISCHOFBERGER, FRANC HETZER, RENE WARSCHKOW, MARCEL ZADNIKAR, WALTER BRUNNER, BERNHARD WIDMANN1 & BRUNO SCHMIED, LUKAS MARTI. CITATION: LANGENBECKS ARCH SURG. 2016; 401: 519¿529. DOI: 10.1007/S00423-016-1431-2. PERINEAL STAPLED PROLAPSE RESECTION (PSP) IS A RELATIVELY NEW PROCEDURE USED TO TREAT COMPLETE EXTERNAL RECTAL PROLAPSE. IT WAS DEVELOPED FROM STAPLED TRANSANAL RECTAL RESECTION (STARR) WHICH ALLEVIATES OBSTRUCTED DEFECATION SYNDROME BY REMOVING RECTAL INTUSSUSCEPTION WITH A CONTOUR TRANSTAR STAPLER (ETHICON). THIS STUDY AIMS TO ASSESS LONG-TERM RESULTS AFTER PSP. THE ANALYSIS WAS BASED ON THE 64 CASES OF PSPS (62 FEMALE AND 2 MALE PATIENTS; AGE RANGE: 68.2 TO 84.7 YEARS OLD; BMI: 23.3) PERFORMED CONSECUTIVELY BETWEEN AUGUST 2007 AND OCTOBER 2015 AT THE (B)(6). DURING THE PROCEDURE, THE COMPLETELY EXTRACTED PROLAPSE WAS OPENED WITH A LINEAR STAPLER WITH ONE OR MULTIPLE FIRINGS AND THEN STEPWISE RESECTED WITH CONTOUR TRANSTAR STAPLER (ETHICON) PARALLEL TO THE DENTATE LINE. REPORTED COMPLICATIONS INCLUDED MALFUNCTION OF THE STAPLER IN AN EXCEPTIONALLY THICK AND VULNERABLE PROLAPSE LEADING TO A LARGE DEFECT (N-1) WHICH REQUIRED CONVERSION TO ALTERMEIER¿S RECTOSIGMOIDECTOMY, MINOR DEHISCENCE OF THE STAPLE LINE (N-3) WHICH WAS OVERSEWN WITHOUT FURTHER CONSEQUENCES, AND RECURRENCE OF RECTAL PROLAPSE (N-19) WHICH REQUIRED RE-OPERATION (N-16), ALTEMEIER¿S RECTOSIGMOIDECTOMY IN ANOTHER HOSPITAL (N-1), AND SECOND PSP PROCEDURE (N-2). IT WAS CONCLUDED THAT PSP IS AN EASY-TO-PERFORM PROCEDURE FOR RECTAL PROLAPSE. IT IS ASSOCIATED WITH A LOW MORBIDITY, HIGH PATIENTS¿ SATISFACTION, AND GOOD FUNCTIONAL OUTCOME. IT IS LIKELY TO BE A GOOD ALTERNATIVE TO THE OTHER PERINEAL PROCEDURES SUCH AS ALTEMEIER¿S OR REHN-DELORME¿S PROCEDURE, WHICH ARE MORE COMPLEX TO PERFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564820 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036002878

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention