BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 7728757 · Received July 27, 2018

    Report

    Report Number
    3005075853-2018-11660
    Event Type
    Injury
    Date Received
    July 27, 2018
    Date of Event
    January 1, 2005
    Report Date
    July 3, 2018
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    TITLE SAFETY OF LAPAROSCOPIC INTRACORPOREAL RECTAL TRANSECTION WITH DOUBLE-STAPLING TECHNIQUE ANASTOMOSIS. AUTHOR: SEIICHIRO YAMAMOTO, MD, PHD, SHIN FUJITA, MD, PHD, TAKAYUKI AKASU, MD, PHD, AND YOSHIHIRO MORIYA, MD, PHD. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH 2005;15:70¿74. THE AIM OF THE PRESENT STUDY WAS TO ASSESS THE FEASIBILITY AND ANALYZE THE SHORT-TERM OUTCOMES OF LAPAROSCOPIC INTRACORPOREAL RECTAL TRANSECTION WITH DOUBLE-STAPLING TECHNIQUE (DST) ANASTOMOSIS, ONE OF THE MOST DEMANDING AND STRESSFUL TECHNIQUES IN LAPAROSCOPIC COLORECTAL SURGERY, IN SELECTED PATIENTS WITH SIGMOID COLON AND RECTAL CARCINOMA. BETWEEN JUL 2001 AND JAN 2004, 67 PATIENTS UNDERWENT LAPAROSCOPIC SIGMOIDECTOMY AND ANTERIOR RESECTION WITH DST ANASTOMOSIS AND WERE DIVIDED INTO 3 GROUPS BASED ON DISEASE CHARACTERISTICS: SIGMOID COLON/RECTOSIGMOID CARCINOMA (N=36), UPPER RECTAL CARCINOMA (N=21), AND MIDDLE/LOWER RECTAL CARCINOMA (N=10). FOR PROXIMAL SIGMOID COLON CARCINOMA, THE MESENTERY AT THE PROMONTORY WAS EXCISED ROUTINELY USING ULTRASONIC SHEARS (LAPAROSCOPIC COAGULATING SHEARS [LCS]) OR AN ENDOLINEAR STAPLER. FOR RECTOSIGMOIDAL AND UPPER RECTAL LESIONS, MESORECTAL TISSUE EXTENDING DOWN TO 5CM BELOW THE TUMOR WAS EXCISED ROUTINELY USING LCS. INTRACORPOREAL ANASTOMOSIS UNDER A LAPAROSCOPIC VIEW WAS PERFORMED BY MEANS OF THE DST, USING A CIRCULAR STAPLER (ECS 29 OR 33 MM). POSTOPERATIVELY, OVERALL COMPLICATIONS INCLUDED WOUND SEPSIS (N=3), BOWEL OBSTRUCTION (N=2), AND ABSCESS (N=1). REOPERATION OF A LAPAROSCOPIC DIVISION OF AN ADHESIVE BAND FOR A POSTOPERATIVE SMALL BOWEL OBSTRUCTION WAS NECESSARY IN 1 PATIENT WITH SIGMOID COLON CARCINOMA THE FINDINGS OF THE PRESENT STUDY DEMONSTRATE THAT LAPAROSCOPIC INTRACORPOREAL RECTAL TRANSECTION WITH DST ANASTOMOSIS CAN BE PERFORMED SAFELY WITHOUT INCREASED MORBIDITY OR MORTALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568105 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention