BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CONTOUR CURVED CUTTER STAPLER

    MDR report key: 22371002 · Received July 1, 2025

    Report

    Report Number
    3005075853-2025-04899
    Event Type
    Injury
    Date Received
    July 1, 2025
    Date of Event
    March 24, 2020
    Report Date
    July 1, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 7/1/2025: THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204. D4: BATCH # UNK. 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. 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: LAPAROSCOPIC RECTAL SURGERY: DOES IMMEDIATE OUTCOME DIFFER IN RESPECT TO SEX? AUTHOR(S): JUAN MANUEL SANCHEZ HIDALGO, M.D., PH.D.; EDUARD M. TARGARONA, M.D., PH.D.; CARMEN MARTINEZ, M.D.; PILAR HERNANDEZ, M.D.1; CARMEN BALAGUE, M.D., PH.D.; MANUEL TRIAS, M.D., PH.D. CITATION: DIS COLON RECTUM 2010; 53: 438¿444 / DOI:10.1007/DCR.0B013E3181BDBAA7. THE PURPOSE OF THIS PROSPECTIVE STUDY WAS TO EVALUATE THE IMMEDIATE OUTCOME AFTER THE LAPAROSCOPIC APPROACH TO THE RECTUM IN RELATION TO THE SEX OF THE PATIENT. BETWEEN JANUARY 2000 AND APRIL 2008, A TOTAL OF 239 PATIENTS (N=66.5% MALE, N-33.5% FEMALE) WITH RECTAL CANCER UNDERWENT LAPAROSCOPIC RECTAL SURGERY. IN ALL LAPAROSCOPY PATIENTS, TRANSECTION WAS ACHIEVED LAPAROSCOPICALLY. WE USED AN ENDO GIA STAPLER FOR THIS PURPOSE IN MOST OF THE CASES. BUT IN PATIENTS IN WHOM THE INTRODUCTION OF THE STAPLER WAS DIFFICULT BECAUSE THE DIAMETER OF THE LOWER PELVIS WAS TOO SMALL TO ACHIEVE A SAFE DISTAL MARGIN, THE RECTAL TRANSECTION WAS PERFORMED BY USE OF A CURVED STAPLER (CONTOUR; ETHICON) INTRODUCED THROUGH A HAND-ASSISTED DEVICE (LAP DISC, ETHICON) TO KEEP ADEQUATE PNEUMOPERITONEUM. POSTOPERATIVE COMPLICATIONS INCLUDED MORBIDITY (N=69), ANASTOMOTIC FISTULA (N=41.8%), DINDO GRADE I (N=19), DINDO GRADE II (N=47), DINDO GRADE III (N=15), DINDO GRADE IV (N=3) AND DINDO GRADE V (N=4). WE BELIEVE THAT NO IMPORTANT DIFFERENCES EXIST IN PERIOPERATIVE OUTCOMES BETWEEN MEN AND WOMEN AFTER A LAPAROSCOPIC APPROACH TO RECTUM CANCER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206075 UNKNOWN CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention