BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 19925092 · Received August 6, 2024

    Report

    Report Number
    2210968-2024-08125
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    April 6, 2022
    Report Date
    August 6, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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: HTTPS://DOI.ORG/10.1007/S11701-022-01409-6.

    Description of Event or Problem · 0

    TITLE: ROBOTIC ASSISTED LAPAROSCOPIC COLPOSUSPENSION FOR FEMALE STRESS URINARY INCONTINENCE: A PROSPECTIVE SERIES. WE PRESENT DATA FROM 28 ROBOTIC-ASSISTED LAPAROSCOPIC COLPOSUSPENSION (RALCP) PROCEDURES, REPORTING ON TECHNIQUE, SAFETY AND EFFICACY. THE COOPERS LIGAMENT WAS THEN IDENTIFIED AND CLEARED ALONG THE SUPERIOR ASPECT OF THE PUBIC RAMUS. A FOLEY CATHETER HELPED DELINEATE THE BLADDER NECK AND ASSISTANT HEGAR DILATORS INSERTED IN THE VAGINA HELPED TO DELINEATE THE VAGINA AND STAY LATERAL TO THE URETHRA. ENDOWRIST ROBOT NEEDLE DRIVERS WERE THEN USED TO PLACE 0 ETHIBOND SUTURES THROUGH THE PARAVAGINAL TISSUE LATERAL TO THE MID-URETHRA AND BLADDER NECK, THE OBTURATOR SHELF AND COOPER¿S LIGAMENT. THE REPORTED COMPLICATIONS INCLUDED (N=1) SEROSAL BOWEL INJURY TREATMENT: INTRACORPOREAL REPAIR, (N=1) URINARY TRACT INFECTION TREATMENT: ANTIBIOTICS IN CONCLUSION, ROBOTIC COLPOSUSPENSION IS SAFE AND FEASIBLE WITH SATISFACTORY EARLY FUNCTIONAL OUTCOMES. SIGNIFICANT IMPROVEMENTS WERE SEEN IN QUALITY OF LIFE SCORES AND NUMBER OF PADS USED PER DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265325 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention