BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 7728029 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11635
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    November 1, 2002
    Report Date
    June 29, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036012990
    PMA / PMN Number
    K030925
    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

    TITLE: RESULTS IN THE LONG-TERM COURSE AFTER STAPLED TRANSANAL RECTAL RESECTION (STARR) AUTHOR: KATRIN KOHLER, SIGMAR STELZNER, GUNTER HELLMICH, DIRK LEHMANN, THOMAS JACKISCH, BERNHARD FANKHANEL, HELMUT WITZIGMANN. CITATION: LANGENBECKS ARCH SURG. 2012; 397:771¿778. DOI: 10.1007/S00423-012-0920-1. STAPLED TRANSANAL RECTAL RESECTION (STARR) HAS RECENTLY BEEN RECOMMENDED FOR PATIENTS WITH OBSTRUCTED DEFECATION CAUSED BY RECTOCELE AND RECTAL WALL INTUSSUSCEPTION. THE STUDY INVESTIGATES THE LONG-TERM RESULTS AND PREDICTIVE FACTORS FOR OUTCOME. BETWEEN NOVEMBER 2002 AND FEBRUARY 2007, 80 PATIENTS (69 FEMALES AND 11 MALES; AGE RANGE: 21 TO 80 YEARS OLD) WERE OPERATED ON USING THE STARR PROCEDURE AND INCLUDED IN THE FOLLOWING STUDY. DURING THE PROCEDURE, A SINGLE SHOT OF ANTIBIOTICS IS ADMINISTERED AT INDUCTION OF ANESTHESIA. THE PROCEDURE FOR PROLAPSE AND HEMORRHOIDS ENTAILS USING A SET PPH-01 (ETHICON) WHICH CONTAINS A DILATOR THAT PROTECTS THE HEMORRHOIDAL ZONE AND PROVIDES A GOOD TRANSANAL ACCESS TO THE PROLAPSE. AFTER THAT, THE CIRCULAR STAPLER IS INTRODUCED INTO THE RECTUM AND THE ANTERIOR PART OF THE PROLAPSE IS GENTLY PULLED INTO THE STAPLING DEVICE BY MEANS OF THE TRACTION SUTURES. THE STAPLER IS CLOSED AND ACTUATED, RESECTING THE ANTERIOR HALF OF THE PROLAPSE. REPORTED COMPLICATIONS DURING THE POST-OPERATIVE COURSE INCLUDED BLEEDING (N-5) WHICH WAS TREATED IN THE THEATRE FOR SAFETY REASONS WITHOUT ANY FURTHER COMPLICATION OR THE NEED OF BLOOD TRANSFUSION AND STAPLE LINE INSUFFICIENCY (N-1) WHICH WAS TREATED NON-SURGICALLY. UPON FOLLOW-UP PERIOD, REPORTED COMPLICATIONS INCLUDED UNCHANGED OUTLET OR PERSISTENCE OF ANAL PAIN (N-8), INTRACTABLE URGE (N-6), AND UNCHANGED OUTLET AND INTRACTABLE URGE (N-4). ON LONG-TERM FOLLOW-UP, REPORTED COMPLICATIONS INCLUDED URGE SYMPTOMS (N-10), RECURRENCE OF OUTLET OBSTRUCTION (N-4) WHICH REQUIRED A SECOND STARR PROCEDURE AND 3 PATIENTS INDICATED A RENEWED IMPROVEMENT OF THEIR COMPLAINTS, AND RECURRENCE OF A MUCOSAL PROLAPSE (N-2) WHICH REQUIRED STAPLER HEMORRHOIDOPEXY. THE ADVANTAGE OF THE STARR PROCEDURE IS THE TREATMENT OF THE INTERNAL RECTAL PROLAPSE AND THE RECTOCELE BOTH REPRESENTING THE MAIN ANATOMIC CAUSE FOR ODS. IT AVOIDS POTENTIAL COMPLICATIONS OF A TRANSABDOMINAL APPROACH AND REPRESENTS A NATURAL ORIFICE PROCEDURE. IT WAS CONCLUDED THAT THE STARR IS A SAFE PROCEDURE. A SIGNIFICANT IMPROVEMENT OF SYMPTOMS IS TO BE EXPECTED, BUT THIS IMPROVEMENT MAY DETERIORATE WITH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568266 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036012990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention