BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR TRANSTAR STAPLER SET

    MDR report key: 8809905 · Received July 20, 2019

    Report

    Report Number
    3005075853-2019-20556
    Event Type
    Injury
    Date Received
    July 20, 2019
    Date of Event
    January 1, 2018
    Report Date
    June 25, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002871
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2018. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: LAPAROSCOPIC VENTRAL RECTOPEXY VERSUS STAPLED TRANSANAL RECTAL RESECTION FOR TREATMENT OF OBSTRUCTED DEFECATION IN THE ELDERLY: LONG-TERM RESULTS OF A PROSPECTIVE RANDOMIZED STUDY. AUTHORS: KHALED M. MADBOULY, M.D., PH.D., F.R.C.S.(GLASG.), AHMED D. MOHII, M.D. CITATION: DISEASE OF THE COLON AND RECTUM (2019); 62(1):47-55. DOI: 10.1097/DCR.0000000000001256. THE PURPOSE OF THIS STUDY WAS TO COMPARE LONG-TERM FUNCTIONAL OUTCOME, RECURRENCE RATE, AND QUALITY OF LIFE BETWEEN LAPAROSCOPIC VENTRAL RECTOPEXY AND STAPLED TRANSANAL RECTAL RESECTION IN THE TREATMENT OF OBSTRUCTED DEFECATION. THIS PROSPECTIVE RANDOMIZED STUDY INCLUDED 112 PATIENTS WITH OBSTRUCTED DEFECATION SYNDROME (ODS) ATTRIBUTED TO RECTOCELE OR INTERNAL RECTAL INTUSSUSCEPTION FROM MAY 2013 TO APRIL 2016. PATIENTS WERE RANDOMLY ALLOCATED TO GROUP 1, 56 PATIENTS (11 MALE AND 45 FEMALE; AGE RANGE: 70-85 YEARS; BMI: 28.3 ± 3.4) UNDERWENT LAPAROSCOPIC VENTRAL RECTOPEXY (LVR), OR GROUP 2, 56 PATIENTS (18 MALE AND 38 FEMALE; AGE RANGE: 70-85 YEARS; BMI: 29.1 ± 4.5) UNDERWENT STAPLED TRANSANAL RECTAL RESECTION (STARR). IN GROUP 2, PATIENTS HAD MODIFIED PERINEAL STAPLED RECTAL RESECTION WITH CONTOUR TRANSTAR (ETHICON) FOR FULL-THICKNESS RECTAL RESECTION. REPORTED COMPLICATIONS IN GROUP 2 INCLUDED: BLEEDING (N-2), PERSISTENT OBSTRUCTED DEFECATION (OD) COMPLAINTS (N-6), PROLONGED ANAL PAIN (N-3) WHICH ONLY IMPROVED WITHIN 4 TO 6 MONTHS, ANAL/FECAL INCONTINENCE (N-3), SOILING (N-1), FECAL URGENCY (N-8), DE NOVO ANORECTAL AND PELVIC PAIN (N-3), AND RECURRENCE (N-11) IN WHICH THE PATIENTS RECEIVED BIOFEEDBACK TRAINING, WITH MINIMAL IMPROVEMENT REGARDLESS OF THE ORIGINAL PROCEDURE. IN CONCLUSION, LAPAROSCOPIC VENTRAL RECTOPEXY HAS BETTER LONG-TERM FUNCTIONAL OUTCOME, LESS COMPLICATIONS, AND LESS RECURRENCES COMPARED WITH STAPLED TRANSANAL RECTAL RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603594 CONTOUR TRANSTAR STAPLER SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036002871

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention