BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 23237637 · Received October 7, 2025

    Report

    Report Number
    3005075853-2025-07834
    Event Type
    Injury
    Date Received
    October 7, 2025
    Date of Event
    January 1, 2023
    Report Date
    November 25, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 10/7/2025 B3: EXACT EVENT DATE UNK, ENTERED 1/1/2023 AS ONLY THE YEAR WAS PROVIDED. D4: BATCH # UNK 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. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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.

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 11/25/2025. CORRECTED DATA: B1, B2, H1. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN -NO. 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.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC VERSUS OPEN SURGERY FOR CLOSING THE PELVIC FLOOR PERITONEUM COMBINED WITH EXTRAPERITONEAL STOMA IN RECTAL CANCER AUTHOR: GUAN JINKUN, JI JIN, WANG LIUHUA, WANG WEI, REN JUN, WANG DAORONG. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO INVESTIGATE THE EFFECT OF APPLYING EXTRAPERITONEAL STOMA COMBINED WITH PELVIC FLOOR PERITONEAL RECONSTRUCTION IN APR SURGERY FOR LOW RECTAL CANCER BY TWO DIFFERENT SURGICAL APPROACHES, LAPAROSCOPIC AND OPEN SURGERIES. FROM JANUARY 2016 TO DECEMBER 2021, A TOTAL OF 122 PATIENTS WERE INCLUDED IN THE STUDY. DIVIDED INTO TWO GROUPS: LAPG GROUP (N=59) CASES OF LAPAROSCOPIC SURGERY, INCLUDING 40 MALES AND 19 FEMALES, WITH AN AVERAGE AGE OF (61.68 ± 8.25) YEARS AND A BODY MASS INDEX (BMI) OF (24.56 ± 3.44) KG/M^2. WHILE APR GROUP, (N= 63) CASES OF OPEN SURGERY, INCLUDING 35 MALES AND 28 FEMALES, WITH AN AVERAGE AGE OF (62.22 ± (B)(6) YEARS, BMI (24.40 ± 3.53) KG/M^2. DEVICES WAS USED DURING THE SURGERY INCLUDING STAPLING DEVICE (JOHNSON & JOHNSON, USA, EC60A), 3-0 VICRYL SUTURE (JOHNSON & JOHNSON, USA), STRATAFIX SUTURE (JOHNSON & JOHNSON, USA, SXMD1B405). HEMOLOCK CLIPS (FROM UNKNOWN MANUFACTURER). REPORTED COMPLICATIONS: 3-0 VICRYL SUTURE (JOHNSON & JOHNSON, USA) STRATAFIX SUTURE (JOHNSON & JOHNSON, USA, SXMD1B405). STOMA PROLAPSE (N=?) TREATMENT: NOT REPORTED. STOMA COLLAPSE (N=?) TREATMENT: NOT REPORTED. STOMA STENOSIS (N=?) TREATMENT: NOT REPORTED. BLEEDING FROM THE STOMA (N=?) TREATMENT: NOT REPORTED. PERINEAL INCISION INFECTION (N=?) TREATMENT: NOT REPORTED. PERINEAL INCISION DEHISCENCE (N?) TREATMENT: NOT REPORTED. PERINEAL HERNIA (N=?) TREATMENT: NOT REPORTED. ADHESIVE INTESTINAL OBSTRUCTION (N=?) TREATMENT: NOT REPORTED. PELVIC FLOOR PERITONEAL HERNIA (N=?) TREATMENT: NOT REPORTED. STAPLING DEVICE (JOHNSON & JOHNSON, USA, EC60A) STOMA EDEMA (N=?) TREATMENT: NOT REPORTED. PARASTOMAL HERNIA (N=?) TREATMENT: NOT REPORTED. STOMA STENOSIS (N=?) TREATMENT: NOT REPORTED. BLEEDING FROM THE STOMA (N=?) TREATMENT: NOT REPORTED. PERINEAL INCISION INFECTION (N=?) TREATMENT: NOT REPORTED. PERINEAL INCISION DEHISCENCE (N=?) TREATMENT: NOT REPORTED. PERINEAL HERNIA (N=?) TREATMENT: NOT REPORTED. ADHESIVE INTESTINAL OBSTRUCTION (N=?) TREATMENT: NOT REPORTED. PELVIC FLOOR PERITONEAL HERNIA (N=?) TREATMENT: NOT REPORTED. IN CONCLUSIONS, THE USE OF LAPAROSCOPY FOR EXTRAPERITONEAL STOMA COMBINED WITH PELVIC FLOOR PERITONEAL RECONSTRUCTION IS SAFE AND FEASIBLE, WHICH CAN REDUCE OPERATIVE AND INTRAOPERATIVE BLEEDING, SHORTEN POSTOPERATIVE HOSPITAL STAY, IMPROVE THE NUMBER OF LYMPH NODE DISSECTION, BETTER PROTECT THE PELVIC VEGETATIVE NERVES, AND REDUCE THE INCIDENCE OF SOME PERINEAL COMPLICATIONS, THUS HAS CERTAIN PRACTICAL VALUE IN CLINICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2766969 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other