BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 9209865 · Received October 18, 2019

    Report

    Report Number
    3005075853-2019-22866
    Event Type
    Injury
    Date Received
    October 18, 2019
    Report Date
    September 23, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MDR DECISION: NOT REPORTABLE. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. DOES THE SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. ABSOLUTELY NOT. PERSONALLY I THINK YOUR PRODUCT ARE AMONG THE BEST ON THE MARKET, THAT¿S WAY I CHOOSE THEM FOR MY PATIENTS.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). DATE SENT: 10/18/2019. EVENT DATE UNK. BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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 SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLED: LAPAROSCOPIC INFERIOR MESENTERIC ARTERY PEELING: AN ALTERNATIVE TO HIGH OR LOW VASCULAR LIGATION FOR SIGMOID COLON CANCER RESECTION. AUTHOR/S: ELISA FRANCONE1 ¿ PIERFRANCESCO BONFANTE1 ¿ MARIA SANTINA BRUNO1 ¿DONATELLA INTERSIMONE2 ¿ EMILIO FALCO1 ¿ STEFANO BERTI1. CITATION: WORLD J SURG (2016) 40:2790¿2795; DOI 10.1007/S00268-016-3611-1. THE AIM OF THIS PILOT PROSPECTIVE STUDY IS TO PRESENT THE EXPERIENCE DEVELOPED IN A RAW OF 31 PATIENTS AFFECTED BY SIGMOID CANCER. FROM AUG 2013 TO JULY 2015, 31 PATIENTS (MALE=17, FEMALE=14; MEAN AGE=70 YEARS, AGE RANGE=43-87 YEARS; MEAN BMI=26.3, BMI RANGE=19.3-35.0) WERE SUBMITTED TO LAPAROSCOPIC SIGMOIDECTOMY ASSOCIATED WITH LAPAROSCOPIC INFERIOR MESENTERIC ARTERY PEELING (LIMP). DURING THE PROCEDURE, THE PERITONEAL REFLECTION OF THE RECTUM AT THE SACRAL PROMONTORY WAS INCISED USING THE HARMONIC SCALPEL (HARMONIC ACE +7; ETHICON) TO SEPARATE SUPERIOR MESORECTUM FROM WALDEYER¿S FASCIA. A 5 MM FROM THE AORTIC ORIGIN WAS ACCESSED THE LOOSE LAYER BETWEEN THE VASCULAR SHEATH AND THE TUNICA ADVENTITIA OF THE INFERIOR MESENTERIC ARTERY (IMA) WITH THE HARMONIC SCALPEL, PEELING LYMPH CELLULAR TISSUE ALL AROUND THE VESSEL. FURTHER, ONCE TANGENTIAL PREPARATION OF SUPERIOR MESORECTUM IS ACCOMPLISHED AND SUPERIOR RECTAL ARTERY (SRA) PEELED OFF AND PRESERVED, COLONIC SECTION WAS OBTAINED WITH A 60-MM LAPAROSCOPIC STAPLER (ECHELON FLEX, ENDOPATH; ETHICON). REPORTED COMPLICATION INCLUDED ANASTOMOTIC LEAK ON THE FIFTH POST-OPERATIVE DAY TO AN (B)(6) FEMALE PATIENT. THE PATIENT WAS SUBMITTED TO LAPAROSCOPIC PERITONEAL CAVITY LAVAGE AND COLOSTOMY, AND SHE WAS DISCHARGED ON 11TH POSTOPERATIVE DAY. IN CONCLUSION, GIVEN A PROPER SELECTION OF PATIENTS, LAPAROSCOPIC SIGMOIDECTOMY COMPREHENSIVE OF SUB ADVENTITIAL IMA SKELETONIZATION FROM ITS AORTIC ORIGIN COULD PROVIDE GOOD ONCOLOGICAL OUTCOMES AND RECANALIZATION RATE. FURTHER DATA ARE ADVOCATED TO CONFIRM THESE PRELIMINARY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005502 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention