BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN)

    MDR report key: 8904388 · Received August 18, 2019

    Report

    Report Number
    3005075853-2019-21328
    Event Type
    Injury
    Date Received
    August 18, 2019
    Date of Event
    January 1, 2007
    Report Date
    July 24, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). PUBLICATION YEAR OF 2007. 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: LAPAROSCOPIC VENTRAL RECTOPEXY, POSTERIOR COLPORRHAPHY AND VAGINAL SACROCOLPOPEXY FOR THE TREATMENT OF RECTO-GENITAL PROLAPSE AND MECHANICAL OUTLET OBSTRUCTION, AUTHOR : S. SLAWIK*, R. SOULSBY*, H. CARTER¿, H. PAYNE¿ AND A. R. DIXON. CITATION: COLORECTAL DISEASE (2007); 10:138¿143. DOI:10.1111/J.1463-1318.2007.01259.X. WHILST TRANS-ABDOMINAL FIXATION RESECTION OFFERS BETTER FUNCTIONAL RESULTS AND LOWER RECURRENCE THAN PERINEAL PROCEDURES, MESH RECTOPEXY IS COMPLICATED BY CONSTIPATION. LAPAROSCOPIC AUTONOMIC NERVE-SPARING, VENTRAL RECTOPEXY ALLOWS CORRECTION OF THE UNDERLYING ABNORMALITIES OF THE RECTUM, VAGINA, BLADDER AND PELVIC FLOOR. BETWEEN JANUARY 1997 AND DECEMBER 2005, 80 PATIENTS (6 MALE AND 74 FEMALE; MEDIAN AGE: 59 YEARS; AGE RANGE: 31¿90 YEARS; BMI: 19¿36) UNDERWENT NOVEL LAPAROSCOPIC PROLAPSE SURGERY FOR FULL THICKNESS PROLAPSE AND/OR MECHANICAL OUTLET OBSTRUCTION. A HARMONIC SCALPEL (ETHICON) IS USED FOR THE DISSECTION. A 15 X 15 CM PROLENE POLYPROPYLENE MESH (ETHICON) IS TRIMMED IN THE HYPOTENUSE AXIS TO 3 X 17 CM, THE LAST 7 CM TAPERING TO 1 CM. THE MESH IS SUTURED TO THE VENTRAL ASPECT OF THE SEROMUSCULAR WALL OF THE RECTUM USING THREE, INTERRUPTED, NON-ABSORBABLE SUTURES ETHIBOND 0 (ETHICON). THE POSTERIOR WALL OF THE VAGINA IS THEN SUTURED TO THE VENTRAL ASPECT OF THE MESH WITH THREE SUTURES AS BEFORE. THE MOST CRANIAL IS SUTURED TO THE POSTERIOR VAGINAL FORNIX. THE TAPERED END OF MESH IS FIXED TO THE SACRAL PROMONTORY WITHOUT PLACING ANY PARTICULAR TRACTION ON THE RECTUM. DURING THE RESECTION RECTOPEXY, THE UPPER 1/3 OF THE RECTUM IS DIVIDED USING A LINEAR CUTTER (ETHICON). THE UMBILICAL PORT IS EXTENDED EITHER SIDE OF THE UMBILICUS IN THE MIDLINE TO ALLOW DELIVERY OF THE BOWEL. THE PROXIMAL BOWEL AND HEAD OF A CIRCULAR STAPLING DEVICE (ETHICON) IS RETURNED TO THE ABDOMINAL CAVITY AND THE INCISION IS CLOSED AROUND THE RE-INTRODUCED UMBILICAL PORT. REPORTED COMPLICATIONS INCLUDED FECAL IMPACTION (N-3), EXTRACTION PORT SITE INFECTION (N-1), WOUND INFECTION (N-2%), BLEEDING (N-1), RESECTION RECTOPEXY ANASTOMOSIS LEAKED (N-1) WHICH REQUIRED A TEMPORARY LOOP ILEOSTOMY, URINARY RETENTION (N-1), MINOR EVACUATORY DIFFICULTIES (N-3) WHICH WERE MANAGED WITH A COMBINATION OF SENNA AND ENEMAS. AND TWO, URINARY STRESS INCONTINENCE (N-2) WHICH RESPONDED TO A TVT SLING. IN CONCLUSION, LAPAROSCOPIC VENTRAL RECTOPEXY IS SAFE WITH RELATIVELY LOW MORBIDITY. IN THE MEDIUM-TERM, IT PROVIDES GOOD RESULTS FOR PROLAPSE AND ASSOCIATED SYMPTOMS OF INCONTINENCE AND OBSTRUCTED DEFECATION..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698186 PROXIMATE*55MM LINEAR CUTTER (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention