BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX 60MM 34CM SHAFT

    MDR report key: 22382415 · Received July 2, 2025

    Report

    Report Number
    3005075853-2025-05063
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    December 5, 2019
    Report Date
    July 2, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/2/2025. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. B3: UNKNOWN; CAPTURED AS AWARENESS DATE. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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: HOW WERE THE COMPLICATIONS REPORTED ADDRESSED - THE LSEA GROUP ANASTOMOTIC LEAKAGE, CHYLOTHORAX AND THE POST-OPERATIVE DYSPHAGIA? HOW WERE THE COMPLICATIONS REPORTED ADDRESSED - THE CEEA GROUP ANASTOMOTIC LEAKAGE, DIAPHRAGMATIC HERNIA, MEDIASTINITIS AND POST-OPERATIVE DYSPHAGIA? 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: ROBOTIC SIDE-TO-SIDE AND END-TO-SIDE STAPLED ESOPHAGOGASTRIC ANASTOMOSIS OF IVOR LEWIS ESOPHAGECTOMY FOR CANCER AUTHORS: HANLU ZHANG, ZIHAO WANG, YU ZHENG, YINGCAI GENG, FUQIANG WANG, LONG-QI CHEN, YUN WANG. CITATION: WORLD J SURG (2019) 43:3074¿3082; DOI: HTTPS://DOI.ORG/10.1007/S00268-019-05133-5. THE AIMED OF THIS RETROSPECTIVE STUDY WAS TO REVIEW THE ROBOTIC INTRATHORACIC ALIMENTARY TRACT RECONSTRUCTION AND TO COMPARE THE SHORT-TERM SURGICAL OUTCOMES OF LINEAR-STAPLED SIDE-TO-SIDE ESOPHAGOGASTRIC ANASTOMOSIS (LSEA) AND CIRCULAR-STAPLED END-TO-SIDE ESOPHAGOGASTRIC ANASTOMOSIS (CEEA) IN ROBOTIC IVOR LEWIS ESOPHAGECTOMY. FROM FEBRUARY 2016, TO DECEMBER 2018, 77 PATIENTS WHO UNDERWENT COMPLETELY ROBOTIC IVOR LEWIS ESOPHAGECTOMY IN WHICH 35 PATIENTS (MALE=33, FEMALE=2; MEAN AGE=61.4 ± 9.2; MEAN BMI=22.6 ± 4.4) WERE CATEGORIZED INTO THE LSEA GROUP AND 42 PATIENTS (MALE=35, FEMALE=7; MEAN AGE=61.9 ± 7.8; MEAN BMI=22.9 ± 2.2) WERE CATEGORIZED INTO THE CEEA GROUP. DURING THE PROCEDURE, FROM THE INCISURA ON THE LESSER CURVE TO THE FUNDUS, A GASTRIC CONDUIT WAS CREATED USING FOUR TO SIX FIRINGS OF AN ENDOSCOPIC LINEAR STAPLER (ECHELON FLEX POWERED ENDOPATH; ETHICON). THE STAPLE LINE WAS OVER-SEWN WITH BARBED SUTURE (STRATAFIX SPORAL 3/0, ETHICON). THEN, THE GAP OF THE ANTERIOR WALL WAS CLOSED WITH CONTINUOUS SINGLE-LAYER BARBED SUTURE (STRATAFIX SPORAL 3/0, ETHICON). SPECIMEN. THE END-TO-SIDE ANASTOMOSIS WAS COMPLETED USING A 25-MM CIRCULAR STAPLER WITH 3.5-MM STAPLES (CDH STAPLER, ETHICON), AND THEN, THE GASTROTOMY WAS TRANSECTED WITH A LINEAR STAPLER. REPORTED COMPLICATIONS IN LSEA GROUP INCLUDED ANASTOMOTIC LEAKAGE (N=3); CHYLOTHORAX (N=1); POST-OPERATIVE DYSPHAGIA (N=2). REPORTED COMPLICATIONS IN CEEA GROUP INCLUDED ANASTOMOTIC LEAKAGE (N=2); DIAPHRAGMATIC HERNIA (N=1); MEDIASTINITIS (N=1); POSTOPERATIVE DYSPHAGIA (N=7). IN CONCLUSION, IN ROBOTIC IVOR LEWIS ESOPHAGECTOMY, BOTH LSEA AND CEEA WERE FEASIBLE AND SAFE TO PERFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2359585 PWRD ECH FLEX 60MM 34CM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention