BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 8816641 · Received July 23, 2019

    Report

    Report Number
    3005075853-2019-20665
    Event Type
    Injury
    Date Received
    July 23, 2019
    Report Date
    June 26, 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 · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2010. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: QUO VADIS STARR? A PROSPECTIVE LONG-TERM FOLLOW-UP OF STAPLED TRANSANAL RECTAL RESECTION FOR OBSTRUCTED DEFECATION SYNDROME AUTHOR: OLIVER ZEHLER, YOGESH K. VASHIST, DEAN BOGOEVSKI, MAXIMILLIAN BOCKHORN, EMRE F. YEKEBAS, JAKOB R. IZBICKI, ASAD KUTUP CITATION: J GASTROINTEST SURG (2010) 14:1349¿1354; DOI 10.1007/S11605-010-1261-4; PUBLISHED ONLINE: 2 JULY 2010. THIS PROSPECTIVE STUDY AIMED TO EVALUATE THE LONG-TERM CLINICAL OUTCOME AFTER STARR AS A TREATMENT OPTION FOR ODS CAUSED BY AN ISOLATED AND SYMPTOMATIC RECTOCELE. BETWEEN JANUARY 2001 AND MARCH 2004, 20 PATIENTS WITH MEAN AGE 60.5 (RANGE 45.3-78.6) (MALE N=1, FEMALE N=19) WITH AN ISOLATED AND SYMPTOMATIC RECTOCELE DUE TO OBSTRUCTED DEFECATION SYNDROME WERE SUBJECTED TO STARR. TWO PPH01 CIRCULAR STAPLERS WERE USED (ETHICON ENDO-SURGERY, NORDERSTEDT, GERMANY). A CIRCULAR ANAL DILATATOR (CAD 33) WAS GENTLY INTRODUCED INTO THE ANUS. THE ANOSCOPE (PSA 33) WAS INTRODUCED INTO THE CAD 33, AND THREE HALF (180°) ANTERIOR PURSE STRINGS WITH PROLENE 2¿0 (ETHICON), INCLUDING PROLAPSED RECTAL WALL WITH MUCOSA, SUBMUCOSA AND RECTAL MUSCLE WALL, WERE PLACED AT LEAST 5 CM ABOVE THE DENTATE LINE. THE OPENED CIRCULAR STAPLER WAS INTRODUCED, AND THE ANVIL WAS PLACED ABOVE THE ANTERIOR HALF PURSE STRINGS WHILST KEEPING THE SUTURES UNDER TENSION, THE STAPLER DEVICE WAS THEN CLOSED, FIRED AND GENTLY WITHDRAWN. THE POSTERIOR CIRCUMFERENTIAL STAPLED LINE (SO-CALLED BRIDGE) WAS TRANSECTED AND THE MUCOSAL ENDINGS WERE SUTURED WITH 3-0 VICRYL (ETHICON). COMPLICATIONS INCLUDED POSTOPERATIVE BLEEDING (N=2) WHICH REQUIRED IMMEDIATE REOPERATION AND INCREASING LOCAL GRANULOMATOUS REACTION AT THE STAPLER LINE WITH PROLONGED BLEEDING (N=1) WHICH WAS SUCCESSFULLY REOPERATED 4 WEEKS AFTER THE PRIMARY SURGERY BY REMOVAL OF THE STAPLER LINE. IN CONCLUSION, THE STARR PROCEDURE IS AN EFFECTIVE OPERATION IN ISOLATED SYMPTOMATIC RECTOCELES WITH REGARD TO RELIEF OF THE OBSTRUCTED DEFECATION SYNDROME. THE SHORT-TERM IMPROVEMENT AFTER STARR PREDICTS LONG-TERM OUTCOME IN OBSTRUCTED DEFECATION SYNDROME CAUSED BY A RECTOCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610720 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036012993

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention