BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 19992120 · Received August 15, 2024

    Report

    Report Number
    2210968-2024-08561
    Event Type
    Injury
    Date Received
    August 15, 2024
    Date of Event
    November 21, 2023
    Report Date
    August 15, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    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: LAPAROSCOPIC, ENDOSCOPIC AND ROBOTIC SURGERY 6 (2023) 154-159; HTTPS://DOI.ORG/10.1016/J.LERS.2023.11.005.

    Description of Event or Problem · 0

    TITLE: MEDIUM-TERM OUTCOMES OF LAPAROSCOPIC PUBOCERVICAL FASCIA RECONSTRUCTION AND SACROSPINOUS LIGAMENT FIXATION WITH POSTERIOR APPROACH FOR A PELVIC ORGAN PROLAPSE: A RETROSPECTIVE STUDY OF 124 CASES. THIS STUDY AIMS TO INVESTIGATE THE MEDIUM-TERM EFFICACY OF LAPAROSCOPIC PUBOCERVICAL FASCIA RECONSTRUCTION AND SACROSPINOUS LIGAMENT FIXATION FOR PATIENTS WITH SEVERE PELVIC ORGAN PROLAPSE. BETWEEN SEPTEMBER 2016 AND DECEMBER 2020, 124 PATIENTS WITH SEVERE PELVIC ORGAN PROLAPSE QUANTITATION STAGE III-IV WHO UNDERWENT LAPAROSCOPIC PUBOCERVICAL FASCIA RECONSTRUCTION AND SACROSPINOUS LIGAMENT FIXATION WITH A POSTERIOR APPROACH WERE INCLUDED IN THE STUDY. THE PATIENT¿S MEDIAN AGE WAS 63.5 YEARS, RANGING FROM 39 TO 80, AND THE MEAN BMI WAS 23.90 ± 2.76 KG/M2. DURING THE PROCEDURE, A 1-0 NON-ABSORBABLE ETHIBOND POLYESTER SUTURES (ETHICON) WITH AN ATTACHED NEEDLE WAS USED TO REPAIR THE PUBOCERVICAL FASCIA DEFECT. THE RECONSTRUCTION OF THE PUBOCERVICAL FASCIA WAS CONTINUED WITH 6-8 PLICATIONS DEPENDING ON THE PATIENT'S ANATOMY. IF THE PATIENT REQUESTED TO RETAIN THE UTERUS, THE PUBIC END OF THE PUBOCERVICAL FASCIA DEFECT WAS SUTURED TO THE ANTERIOR PART OF THE CERVIX TO REPAIR THE PUBOCERVICAL FASCIA. IF THE UTERUS WAS EXCISED, THE PUBOCERVICAL FASCIA DEFECT AT THE PUBIC END AND THE POSTERIOR VAGINAL WALL FASCIA WERE SUTURED AND FIXED TO THE VAGINAL STUMP. AFTER THE PUBOCERVICAL FASCIA WAS SUTURED WITHOUT TYING, LAPAROSCOPIC SACROSPINOUS LIGAMENT FIXATION WAS PERFORMED WITH A POSTERIOR APPROACH. A 1-0 NONABSORBABLE ETHIBOND POLYESTER SUTURE (ETHICON) WITH THE ATTACHED NEEDLE WAS USED IN LAPAROSCOPIC SACROSPINOUS LIGAMENT FIXATION. AFTER ALL THE SUTURES WERE COMPLETED, HYSTERECTOMY WAS PERFORMED, AND THE VAGINAL STUMP WAS SUTURED WITH A NON-ETHICON 1-0 ABSORBABLE SUTURE (MANUFACTURER: UNKNOWN). REPORTED COMPLICATIONS INCLUDED URINARY INCONTINENCE (N=6), LEG PAIN (N=2), BUTTOCK PAIN (N=2), SUTURE EXPOSURE AND GRANULATION ACCOMPANIED BY CONTINUOUS DRIP BLEEDING OF THE VAGINA WITHIN 2 YEARS AFTER THE OPERATION (N=1), AND RECURRENCE OF PELVIC ORGAN PROLAPSE (N=14). IN CONCLUSION, LAPAROSCOPIC PUBOCERVICAL FASCIA RECONSTRUCTION AND SACROSPINOUS LIGAMENT FIXATION WITH THE POSTERIOR APPROACH IS A SAFE, MINIMALLY INVASIVE, AND EFFECTIVE METHOD FOR PATIENTS WITH SEVERE PELVIC ORGAN PROLAPSE. LONG-TERM FOLLOW-UP IS NEEDED TO CONFIRM THE CLINICAL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1640877 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention