BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 7748449 · Received August 3, 2018

    Report

    Report Number
    3005075853-2018-11860
    Event Type
    Injury
    Date Received
    August 3, 2018
    Report Date
    July 10, 2018
    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). BATCH # UNK. ONLY PUBLICATION YEAR (2015) 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: HARTMANN¿S PROCEDURE AND LAPAROSCOPIC REVERSAL VERSUS PRIMARY ANASTOMOSIS AND ILEOSTOMY CLOSURE FOR LEFT COLONIC PERFORATION. AUTHOR : D. C. STEINEMANN, T. STIERLE, A. ZERZ, S. H. LAMM1 , P. LIMANI, A. NOCITO. CITATION: LANGENBECKS ARCH SURG. 2015; 400: 609¿616. DOI: 10.1007/S00423-015-1319-6. THE PRESENT STUDY USED A CASE-MATCH APPROACH WITH THE AIM OF COMPARING TWO STRATEGIES; THE COMBINED MORBIDITY OF HARTMANN¿S PROCEDURE (HP) FOLLOWED BY LAPAROSCOPIC HARTMANN¿S REVERSAL (LHR [STRATEGY A]) TO THAT OF SIGMOID RESECTION WITH PRIMARY ANASTOMOSIS (PA) AND DIVERTING ILEOSTOMY FOLLOWED BY ILEOSTOMY CLOSURE (IC [STRATEGY B]) IN PATIENTS WITH BENIGN LEFT-SIDED COLONIC PERFORATION AND GENERALIZED PERITONITIS. THE STUDY INCLUDED A TOTAL OF 64 PATIENTS, OF WHICH, 32 PATIENTS WERE RANDOMIZED UNDER STRATEGY A (15 MALE AND 17 FEMALE PATIENTS; AGE RANGE: 67 TO 83 YEARS OLD; BMI: 22 TO 31) AND STRATEGY B (12 MALE AND 20 FEMALE PATIENTS; AGE RANGE: 64 TO 81 YEARS OLD; BMI: 22 TO 28). DURING THE PROCEDURE IN STRATEGY A, RESECTION OF THE INVOLVED RECTOSIGMOID OR THE LEFT HEMICOLON WAS DONE IF NECESSARY THROUGH A MIDLINE LAPAROTOMY. THE RECTAL STUMP WAS CLOSED USING A CONTOUR CURVED CUTTER STAPLER (ETHICON). DURING THE PROCEDURE IN STRATEGY B, MOBILIZATION OF THE LEFT COLON AND THE SPLENIC FLEXURE INCLUDING LIGATION OF THE INFERIOR MESENTERIC VESSELS WERE PERFORMED TO CREATE TENSION-FREE TRANSANALLY STAPLED COLORECTAL ANASTOMOSIS USING CDH 29 STAPLER (ETHICON). IN THE STRATEGY A GROUP, REPORTED COMPLICATION INCLUDED ANASTOMOTIC LEAKAGE (N-1). IN THE STRATEGY B GROUP, REPORTED COMPLICATIONS INCLUDED INTRA-ABDOMINAL ABSCESS WITHOUT EVIDENCE OF ANASTOMOTIC LEAKAGE (N-2) WHICH REQUIRED RE-OPERATION AND WOUND INFECTION WITH FASCIA NECROSIS (N-1) WHICH REQUIRED WOUND REVISION UNDER GENERAL ANESTHESIA. IT WAS CONCLUDED THAT THE PA PROCEDURE WITH ILEOSTOMY MIGHT STILL BE THE BETTER CHOICE WHEN THE PATIENT¿S CONDITION DOES ALLOW PA. ON THE OTHER HAND, LHR IS FEASIBLE IN A LARGE PROPORTION OF UNSELECTED PATIENTS WITH A RELATIVELY HIGH REVERSAL RATE AND MODERATE MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590969 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention