BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 9465330 · Received December 13, 2019

    Report

    Report Number
    3005075853-2019-24250
    Event Type
    Injury
    Date Received
    December 13, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2013. BATCH # UNK. 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. 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 (CIRCULAR STAPLER) CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. DID THE PATIENT CARE POST OP CHANGE HOW THE PATIENT WAS TREATED DUE TO THE BLOOD LOSS? IF YES, PLEASE EXPLAIN? HOW IS THE PATIENT(S) DOING CURRENTLY? (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: TOTAL LAPAROSCOPIC SIGMOID AND RECTAL SURGERY IN COMBINATION WITH TRANSANAL ENDOSCOPIC MICROSURGERY: A PRELIMINARY EVALUATION IN CHINA. AUTHOR : YI HAN ¿ YONG-GANG HE ¿ HAO-BO ZHANG ¿ KE-ZHI LV ¿ YA-JIE ZHANG ¿ MOU-BIN LIN ¿ LU YIN. CITATION: SURG ENDOSC (2013) 27:518¿524; DOI 10.1007/S00464-012-2471-5. THIS PROSPECTIVE STUDY WAS TO EVALUATE THE FEASIBILITY AND SAFETY OF TOTAL LAPAROSCOPIC SIGMOID AND RECTAL SURGERY WITHOUT ABDOMINAL INCISION IN COMBINATION WITH TRANSANAL ENDOSCOPIC MICROSURGERY (TEM). FROM MAY 2010 TO OCTOBER 2011, 34 PATIENTS (MALE=19, FEMALE=15; MEAN AGE=56.5 YEARS, AGE RANGE=41-78 YEARS; MEAN BMI=24.6, BMI RANGE=19.8-30.3) WITH COLON AND RECTAL TUMORS WERE TREATED BY TOTAL LAPAROSCOPIC SURGERY. DURING THE PROCEDURE, A CIRCUMFERENTIAL INCISION OF THE RECTUM AT LEAST 2 CM BELOW THE TUMOR WAS MADE BY USING A HARMONIC SCALPEL (ETHICON) LAPAROSCOPICALLY. TO DELIVER MOBILIZED RECTUM AND SIGMOID COLON THROUGH RESECTOSCOPE AND FINISH THE ANASTOMOSIS, A CIRCULAR STAPLER (COVIDEN OR ETHICON DST SERIES EEA 33 MM) WAS INSERTED TRANSANALLY, AND AN END-TO-END ANASTOMOSIS WAS LAPAROSCOPICALLY CREATED UNDER DIRECT VISUAL CONTROL. IN CASE THE COLON COULD NOT BE SUFFICIENTLY MOBILIZED TO BE PULLED OUT THROUGH THE ANUS, THE PROXIMAL COLON WAS RESECTED TRANSVERSELY USING A HARMONIC SCALPEL. REPORTED COMPLICATIONS INCLUDED AVERAGE BLOOD LOSS OF 200.2 ML (RANGE 55-450 ML) [HARMONIC SCALPEL (N=?), CIRCULAR STAPLER (N=?)]; AND POST-OPERATIVE ANASTOMOTIC LEAKAGE [CIRCULAR STAPLER (N=?)] IN WHICH FIVE WERE CONSERVATIVELY TREATED WITH PELVIC LAVAGE, FASTING, AND TOTAL PARENTERAL NUTRITION FOR 2¿6 WEEKS, ONLY ONE PATIENT UNDERWENT SECONDARY ILEOSTOMY. IN CONCLUSION, THIS PRELIMINARY STUDY INDICATED THAT TOTAL LAPAROSCOPIC SIGMOID AND RECTAL SURGERY IN COMBINATION WITH TEM WAS A SAFE, FEASIBLE, AND MINIMALLY INVASIVE TECHNIQUE. THIS ADVANCED SURGICAL TECHNIQUE WAS DEVELOPED BY COMBINING LAPAROSCOPY WITH THE CONCEPT OF NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264650 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention