BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 15707442 · Received November 1, 2022

    Report

    Report Number
    3005075853-2022-07440
    Event Type
    Injury
    Date Received
    November 1, 2022
    Date of Event
    February 14, 2022
    Report Date
    November 1, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUBLICATION DATE 2022, EXACT EVENT DATE UNK. BATCH # UNK. 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 CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    TITLE: CLINICAL UTILITY OF NEAR-INFRARED PERFUSION ASSESSMENT OF THE GASTRIC TUBE DURING IVOR LEWIS ESOPHAGECTOMY. AUTHORS: ELKE VAN DAELE, NAOMI DE BRUYNE, HANNE VANOMMESLAEGHE, YVES VAN NIEUWENHOVE, WIM CEELEN, PIET PATTYN. CITATION: SURGICAL ENDOSCOPY (2022) 36:5812¿5821, HTTPS://DOI.ORG/10.1007/S00464-022-09091-3. THIS STUDY EVALUATED THE FEASIBILITY AND EFFICACY OF GASTRIC TUBE INDOCYANINE GREEN ANGIOGRAPHY AFTER IVOR LEWIS ESOPHAGECTOMY. BETWEEN JANUARY 2016 AND DECEMBER 2020, 266 PATIENTS WHO UNDERWENT ELECTIVE IVOR LEWIS ESOPHAGECTOMY WITH GASTRIC TUBE RECONSTRUCTION FOR ESOPHAGOGASTRIC CANCER WERE INCLUDED IN THE STUDY. THERE WERE 216 MALES AND 50 FEMALES WITH A MEAN AGE OF 66 YEARS AND A MEAN BMI OF 25.4 KG/M2. FROM THIS GROUP, INDOCYANINE GREEN ANGIOGRAPHY WAS USED IN 115(STUDY GROUP) WHILE IN THE REMAINING 151 PATIENTS SURGERY WAS PERFORMED WITHOUT PERIOPERATIVE INDOCYANINE GREEN ANGIOGRAPHY (CONTROL GROUP). DURING THE PROCEDURE, THE STOMACH WAS TUBULARIZED TO CREATE A 3 CM GASTRIC CONDUIT USING AN ECHELON FLEX¿ POWERED STAPLER (ETHICON ENDOSURGERY). INDOCYANINE GREEN ANGIOGRAPHY WAS PERFORMED USING A COMPETITOR¿S INDOCYANINE GREEN (MANUFACTURER:PULSION MEDICAL SYSTEMS). THE ESOPHAGOGASTRIC ANASTOMOTIC TECHNIQUE WAS PERFORMED WITH INTRATHORACIC END-TO-SIDE CIRCULAR ANASTOMOSIS USING A COMPETITORS¿ 25- OR 28-MM CIRCULAR STAPLER (MANUFACTURER: MEDTRONIC). POSTOPERATIVELY, PATIENTS WERE TREATED ACCORDING TO AN ENHANCED RECOVERY AFTER SURGERY. THE REPORTED COMPLICATIONS INCLUDED GASTRIC TUBE NECROSIS (N=12). IN CONCLUSION, INDOCYANINE GREEN ANGIOGRAPHY IS SAFE AND FEASIBLE, BUT DID NOT RESULT IN A REDUCTION OF AL. THE INTERPRETATION AND NECESSARY ACTION IN CASE OF PERIOPERATIVE PRESENCE OF ISCHEMIA ON INDOCYANINE GREEN ANGIOGRAPHY HAVE YET TO BE DETERMINED. PROSPECTIVE RANDOMIZED TRIALS ARE WARRANTED TO ANALYZE ITS BENEFIT ON ANASTOMOTIC LEAK IN ESOPHAGEAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438127 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention