BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22289358 · Received June 19, 2025

    Report

    Report Number
    2210968-2025-07097
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    December 22, 2023
    Report Date
    June 19, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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 ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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 NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: INT J GYNAECOL OBSTET. 2024 JUN;165(3):1151-1157. HTTPS://DOI.ORG/10.1002/IJGO.15323 EPUB 2023 DEC 22. PMID: 38140804.

    Description of Event or Problem · 0

    TITLE: PERIOPERATIVE OUTCOMES OF TRANSVAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY AND TRANSUMBILICAL LAPAROENDOSCOPIC SINGLE-SITE SURGERY IN HYSTERECTOMY: A COMPARATIVE STUDY. THE AIM OF THIS STUDY IS TO RETROSPECTIVELY COMPARE THE DATA OF PATIENTS WHO UNDERWENT TRANSVAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNOTES) AND TRANSUMBILICAL LAPAROENDOSCOPIC SINGLE-SITE SURGERY (TU-LESS) HYSTERECTOMY TO DETERMINE THE FEASIBILITY, SAFETY, AND ERAS OUTCOMES OF THE TWO SURGICAL METHODS. BETWEEN OCTOBER 2018 AND DECEMBER 2021, OF THE 314 PATIENTS IN THE STUDY, 157 RECEIVED VNOTES AND THE REMAINING 157 RECEIVED TU-LESS. IN VNOTES GROUP, THE INCISION OF THE PERITONEUM WAS SUTURED AND FIXED TO THE VAGINAL WALL USING A 2¿0 VICRYL SUTURE. FINALLY, WE USED 1¿0 VICRYL SUTURE TO CLOSE THE VAGINAL CUFF AND ANTERIOR AND POSTERIOR PERITONEUM. IN TU-LESS GROUP, WE USED AN ULTRASONIC SCALPEL (ETHICON ENDO-SURGERY LLC, GUAYNABO, PUERTO RICO, USA) TO CUT THE ROUND LIGAMENTS AND FALLOPIAN TUBES BILATERALLY. THE SURGICAL SPECIMEN WAS REMOVED THROUGH AN INCISION IN THE VAGINA, AND THE VAGINAL CUFF AND PERITONEUM WERE CLOSED LAPAROSCOPICALLY USING 2¿0 VICRYL SUTURE. REPORTED COMPLICATIONS ARE: VICRYL SUTURE (1¿0 OR 2-0; ETHICON). INTRAOPERATIVE COMPLICATIONS INCLUDED BLOOD LOSS (N=6). TREATMENT: REQUIRING BLOOD TRANSFUSION FEVER (N=12). TREATMENT: NOT REPORTED VAGINAL BLEEDING (N=5). TREATMENT: NOT REPORTED DIARRHEA (N=1). TREATMENT: NOT REPORTED FEVER WITH DIARRHEA (N=2). TREATMENT: NOT REPORTED. IN CONCLUSION, VNOTES AND TU-LESS SEEM SAFE AND FEASIBLE FOR HYSTERECTOMY, BUT VNOTES HYSTERECTOMY WAS MORE CONDUCIVE TO THE POSTOPERATIVE REHABILITATION OF PATIENTS, WITH LESS TRAUMA, LESS PAIN, AND BETTER COSMETIC EFFECTS THAN TU-LESS HYSTERECTOMY. AS AN EMERGING SURGICAL APPROACH, MORE STUDIES, INCLUDING LARGE-SAMPLE, MULTICENTER, RANDOMIZED CONTROLLED TRIALS, ARE NEEDED TO VALIDATE OUR FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854527 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention