BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 9985348 · Received April 22, 2020

    Report

    Report Number
    3005075853-2020-02275
    Event Type
    Injury
    Date Received
    April 22, 2020
    Report Date
    March 31, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. BATCH # UNKNOWN. (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: LAPAROSCOPIC RESTORATIVE PROCTOCOLECTOMY: SAFETY AND CRITICAL LEVEL OF THE ILEAL POUCH ANAL ANASTOMOSIS. AUTHORS: S. E. DUFF; P. M. SAGAR; M. RAO; D. MACAFEE; T. EL-KHOURY. CITATION: THE ASSOCIATION OF COLOPROCTOLOGY OF GREAT BRITAIN AND IRELAND. 14, 2011; 883¿886; DOI: DOI:10.1111/J.1463-1318.2011.02810.X. THE AIM OF THIS PROSPECTIVE STUDY WAS TO REPORT THE LONGER-TERM RESULTS OF LAPAROSCOPIC-ASSISTED RESTORATIVE PROCTOCOLECTOMY (RPC), WITH PARTICULAR REFERENCE TO SAFETY AND THE LEVEL OF THE STAPLED ILEAL POUCH-ANAL ANASTOMOSIS (IPAA). FROM JULY 2006 TO JULY 2010, 75 PATIENTS (MALE=34; MEDIAN AGE= 35 YEARS, AGE RANGE=15 ¿ 72 YEARS) UNDERWENT RPC WITH IPAA. DURING THE PROCEDURE, THE RECTUM WAS MOBILIZED LAPAROSCOPICALLY AS FAR AS THE PELVIC FLOOR, THEN A SMALL (6 CM) PFANNENSTIEL INCISION WAS MADE TO COMPLETE THE PELVIC DISSECTION AND TO ALLOW PLACEMENT OF A LINEAR CONTOUR DEVICE (ETHICON) TO DIVIDE THE RECTUM AT THE PELVIC FLOOR LEVEL. THE POUCH WAS CONSTRUCTED USING TWO LIMBS OF 20 CM OF ILEUM WITH TWO TO THREE FIRINGS OF A LINEAR STAPLER (TLC 75; ETHICON) AND A DOUBLE STAPLED END-TO-END ANASTOMOSIS WAS CONSTRUCTED WITH A CIRCULAR STAPLER (ELS 29; ETHICON). REPORTED EARLY POSTOPERATIVE COMPLICATIONS INCLUDED PELVIC ABSCESS/COLLECTION (N=6) WHICH 4 PATIENTS WERE READMITTED; ILEUS/SMALL BOWEL OBSTRUCTION (N=5) IN WHICH 2 PATIENTS WERE READMITTED AND MANAGED CONSERVATIVELY; MINOR WOUND INFECTION (N=4) IN WHICH 2 PATIENTS WERE READMITTED; POSTOPERATIVE BLEEDINGS (N=1); MESENTERIC THROMBOSIS (N=1); ABDOMINAL PAIN (N=3) WHICH THE PATIENTS WERE READMITTED; RADIOLOGICAL LEAKAGE (N=5); SMALL LEAK FROM BLIND END OF THE J POUCH (N=1); ANASTOMOTIC STRICTURE (N=1); LONG -TERM COMPLICATION INCLUDED POUCHITIS (N=18); POUCH-ANAL ANASTOMOTIC STRICTURE (N=9) WHICH REQUIRED DILATATION UNDER ANAESTHETIC; POOR FUNCTION (N=6) IN WHICH TWO PATIENTS REQUIRED AN ILEOSTOMY; SMALL BOWEL OBSTRUCTION SECONDARY TO A BAND ADHESION (N=1) WHICH REQUIRED A LAPAROTOMY IN THE SECOND TRIMESTER OF PREGNANCY. IN CONCLUSION, IN LAPAROSCOPIC-ASSISTED RPC A LIMITED PFANNENSTIEL INCISION ALLOWS SAFE CONSTRUCTION OF THE IPAA AT AN APPROPRIATE LEVEL. LAPAROSCOPIC RPC IS SAFE AND THE EMERGING LONG-TERM FOLLOW-UP DATA SHOW THE BENEFIT OF THIS APPROACH, WITH VERY LOW RATES OF SMALL BOWEL OBSTRUCTION AND INCISIONAL HERNIA FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451497 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention