BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*HCS HEMORR CIR STAPL

    MDR report key: 7742178 · Received August 2, 2018

    Report

    Report Number
    3005075853-2018-11798
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    July 6, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    20705036012990
    PMA / PMN Number
    K030925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. ONLY PUBLICATION YEAR (2012) 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: STARR WITH PPH-01 AND CCS30 CONTOUR TRANSTAR FOR OBSTRUCTED DEFECATION SYNDROME AUTHOR: SILVIA SAVASTANO, MD; GIUSEPPE VALENTI, MD; FRANCESCO CAVALLIN, MS AND CLAUDIO MISSAGLIA, MD CITATION: SURGICAL INNOVATION 19(2) 171¿174; 2012, DOI: 10.1177/1553350611425504. THE AIM OF THIS COMPARATIVE PROSPECTIVE STUDY WAS TO COMPARE STARR WHICH USED CIRCULAR PPH-01 STAPLERS (ETHICON ENDO-SURGERY; (B)(4)) AND TRANSTART WHICH USED CONTOUR TRANSTAR CCS30 IN PATIENTS WITH OBSTRUCTIVE DEFECATION SYNDROME (ODS). BETWEEN JANUARY 2007 AND JUNE 2009, 64 FEMALE PATIENTS UNDERWENT STARR FOR ODS (32 STARR, AGE RANGE: 54.1 ± 12.7 AND 32 TRANSTAR, AGE RANGE: 60.5 ± 11.4). NO INTRAOPERATIVE COMPLICATIONS APPEARED IN THE STARR GROUP; HOWEVER, 2 POSTERIOR FLOOR PARTIAL DEHISCENCES OF THE SUTURE OCCURRED IN THE TRANSTAR GROUP AND WERE SOLVED WITH MANUAL INTRAOPERATIVE SUTURE WITH NO CONSEQUENCES IN THE POSTOPERATIVE PERIOD. WITH REGARD TO EARLY COMPLICATIONS, RECTAL BLEEDING WAS REPORTED IN 4 CASES IN THE STARR GROUP: 2 WITHIN 24 HOURS, 1 WITHIN 36 HOURS, AND 1 WITHIN 48 HOURS OF THE OPERATION, ALL OF WHICH WERE SOLVED WITH SURGICAL REVISION. IN THE TRANSTAR GROUP, THE FOLLOWING OCCURRED: A HEMOPERITONEUM THAT WAS TREATED WITH (SYNCHRONOUS) COLOSTOMY AND SUBSEQUENT RECANALIZATION AND 2 PARTIAL DEHISCENCES OF SUTURE RIM THAT WERE TREATED CONSERVATIVELY. WITH REGARD TO LATE COMPLICATIONS, IN THE STARR GROUP, URGENCY IN THE POSTOPERATIVE PERIOD WAS SHOWN BY 29 PATIENTS (29.8%) AT 1 MONTH AND AT 3 MONTHS AND BY 23 PATIENTS (23.7%) AT 6 MONTHS BUT ABSENT IN ALL AT 1 YEAR (3 PATIENTS WERE TREATED WITH PELVIC REHABILITATION). IN THE TRANSTAR GROUP, URGENCY WAS SHOWN BY 6 PATIENTS (18.7%) AT 1 MONTH, WHICH PERSISTED AT 3 AND 6 MONTHS, AND DISAPPEARED AT 1 YEAR IN ALL PATIENTS EXCEPT IN 1 PATIENT (3.2%). FOUR PATIENTS (4.1%) IN THE STARR GROUP AND 1 PATIENT (3.2%) IN THE TRANSTAR GROUP SHOWED HEMATOCHEZIA FOR GRANULOMA DUE TO AGRAPHES, 2 PATIENTS IN THE STARR GROUP DEVELOPED RIM SUTURE STENOSIS THAT WAS SOLVED WITH MANUAL SUTURE, AND 1 PATIENT IN THE STARR GROUP SHOWN FECAL INCONTINENCE THAT WAS SOLVED WITH POSTOPERATIVE PELVIC REHABILITATION. IN CONCLUSION, THE 2 SURGICAL APPROACHES EVALUATED HAVE DEMONSTRATED A SIMILAR INCIDENCE OF COMPLICATIONS AND CONSISTED WITH THE DATA REPORTED IN LITERATURE AND ARE THEREFORE TO BE CONSIDERED AS SAFE TECHNIQUES WHEN PERFORMED BY A SURGEON WITH ENOUGH EXPERIENCE IN THE USE OF THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585242 PROXIMATE*HCS HEMORR CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 20705036012990

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention