BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22439828 · Received July 8, 2025

    Report

    Report Number
    2210968-2025-07959
    Event Type
    Injury
    Date Received
    July 8, 2025
    Date of Event
    March 12, 2025
    Report Date
    July 8, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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: HERNIA. 2025 MAR 12;29(1):115. HTTPS://DOI.ORG/10.1007/S10029-025-03312-Z. PMID: 40072628.

    Description of Event or Problem · 0

    TITLE: BALLOON DISSECTION FOR ROBOTIC TOTALLY EXTRA-PERITONEAL (RTEP) INGUINAL HERNIORRHAPHY: DESCRIPTION OF A MODIFIED TECHNIQUE AND REPORT ON 97 CONSECUTIVE PATIENTS. THE PRIMARY OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE FEASIBILITY AND REPRODUCIBILITY OF THIS APPROACH. OUR SECONDARY OBJECTIVES WERE TO DETERMINE SAFETY AND EFFECTIVENESS, BASED ON RATES OF COMPLICATIONS AND RECURRENCE RATES. FINALLY, WE HAD THE OPPORTUNITY TO EXPLORE THE LEARNING CURVE REQUIRED TO REACH PROFICIENCY FOR ROBOTIC TOTALLY EXTRAPERITONEAL (RTEP) IN THIS COHORT OF CONSECUTIVE PATIENTS INCLUSIVE OF THE FIRST PATIENT UNDERGOING THIS APPROACH BY THE STUDIED SURGEON. BETWEEN FEBRUARY 2023 AND APRIL 2024, A TOTAL OF 97 PATIENTS WERE INCLUDED (87 MALE, 10 FEMALE). THERE WAS A MEAN AGE OF 61 YEARS (RANGE 17¿89) AND MEAN BODY MASS INDEX (BMI) OF 26 KG/M2 (21¿37), WHO UNDERWENT A STANDARDIZED ROBOTIC TOTAL EXTRAPERITONEAL (RTEP) PROCEDURE. A TOTAL OF 122 HERNIAS WERE REPAIRED, COMPRISING 25 BILATERAL HERNIAS (25.8%), 72 UNILATERAL HERNIAS (74.2%), AND 8 RECURRENT HERNIAS (6.6%). THE STUDY POPULATION INCLUDED PATIENTS WITH A HISTORY OF RADICAL PROSTATECTOMY FOR PROSTATE CANCER (2/97, 2.1%) AND THOSE WITH INCARCERATED SCROTAL HERNIAS (2/97, 2.1%). A TOTAL OF 79 (79/97, 81.4%) PATIENTS WERE NON-COMPLEX AND 18 PATIENTS COMPLEX (18/97, 18.6%). USING S-SHAPED ½-INCH RETRACTORS, THE ANTERIOR RECTUS SHEATH IS EXPOSED AND INCISED. TWO OPPOSING STAY SUTURES OF 0 VICRYL ARE PLACED USING A UR-6 NEEDLE (ETHICON, INC., SOMERVILLE, NJ). A ROLLED MEDIUM-WEIGHT POLYPROPYLENE MESH, MEASURING EITHER 3¿ × 5¿ OR 4¿ × 6¿ (BARD DAVOL, INC., WARWICK, RI), IS INTRODUCED AND SECURED OVER THE MYOPECTINEAL ORIFICE WITH UP TO THREE POINTS OF FIXATION USING 3 - 0 ETHIBOND SUTURES WITH AN SH NEEDLE (ETHICON, INC., SOMERVILLE, NJ). REPORTED COMPLICATIONS ARE THE FOLLOWING: 0 VICRYL SUTURE, UR-6 NEEDLE (ETHICON), PERSISTENT SEROMAS (GRADE I CLAVIEN-DINDO SCALE, 2.1%) (N=2), TREATMENT: NOT REPORTED, HEMATOMA (GRADE I CLAVIEN-DINDO SCALE, 1.0%) (N=1), TREATMENT: REQUIRING INTRAOPERATIVE DRAIN PLACEMENT AT THE TIME OF INITIAL SURGERY, POSTOPERATIVE URINARY (GRADE I CLAVIEN-DINDO SCALE, 5.2%) (N=5), TREATMENT: REQUIRING TEMPORARY FOLEY CATHETER INSERTION, 3-0 ETHIBOND SUTURES, SH NEEDLE (ETHICON), PERSISTENT SEROMAS (GRADE I CLAVIEN-DINDO SCALE, 2.1%) (N=2), TREATMENT: NOT REPORTED, HEMATOMA (GRADE I CLAVIEN-DINDO SCALE, 1.0%) (N=1), TREATMENT: REQUIRING INTRAOPERATIVE DRAIN PLACEMENT AT THE TIME OF INITIAL SURGERY, POSTOPERATIVE URINARY (GRADE I CLAVIEN-DINDO SCALE, 5.2%) (N=5), TREATMENT: REQUIRING TEMPORARY FOLEY CATHETER INSERTION. IN CONCLUSION, THE MODIFIED RTEP (ROBOTIC TOTALLY EXTRA-PERITONEAL) TECHNIQUE UTILIZING BALLOON-DISSECTION IS FEASIBLE, REPRODUCIBLE AND TIME EFFICIENT. THIS STUDY DEMONSTRATES ITS SAFETY AND EFFECTIVENESS. BASED ON THE POSITIVE OUTCOMES OBSERVED IN OUR EARLY EXPERIENCE, WE CONCLUDE THAT THE MODIFIED RTEP (ROBOTIC TOTALLY EXTRA-PERITONEAL APPROACH OFFERS A PROMISING ALTERNATIVE TO RTAPP (ROBOTIC TRANS-ABDOMINAL PREPERITONEAL) AND MAY PLAY A VALUABLE ROLE IN THE MANAGEMENT OF INGUINAL AND FEMORAL HERNIAS. HOWEVER, FURTHER STUDIES WITH LARGER SAMPLE SIZES AND EXTENDED FOLLOW-UP ARE NEEDED TO FULLY VALIDATE THE EFFICACY AND SAFETY OF THIS TECHNIQUE, PROVIDE DATA ON SHORT AND LONG-TERM QOL INDICATORS, AND TO COMPARE RTEP TO RTAPP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1844386 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention