BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 21311837 · Received February 5, 2025

    Report

    Report Number
    2210968-2025-01379
    Event Type
    Injury
    Date Received
    February 5, 2025
    Date of Event
    October 4, 2023
    Report Date
    February 25, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE EVENT IS NOT RELATED TO THE DEVICE. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    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/S00383-023-05560-5.

    Description of Event or Problem · 0

    TITLE: EFFICACY OF A MODIFED NEEDLE GRASPER FOR SINGLE-PORT LAPAROSCOPIC HERNIA REPAIR IN CHILDREN: A PROPENSITY SCORE-MATCHED ANALYSIS. THE AIM OF THIS STUDY WAS TO EVALUATE THE OUTCOMES OF A SINGLE-PORT LAPAROSCOPIC PERCUTANEOUS EXTRAPERITONEAL CLOSURE (SLPEC) USING A MODIFIED NEEDLE GRASPER IN CHILDREN AND COMPARE THE RESULTS TO THOSE OF TWO-PORT LAPAROSCOPIC PERCUTANEOUS EXTRAPERITONEAL CLOSURE (TLPEC). A RETROSPECTIVE COHORT ANALYSIS OF SLPEC AND TLPEC SURGERY FROM FEBRUARY 2016 TO JUNE 2021 WAS CONDUCTED AT OUR INSTITUTION. OF 1320 PATIENTS, 1169 WERE INCLUDED IN THE SINGLE-PORT/TWO-PORT CRUDE EVALUATION, WITH 930 IN THE PSM COHORT (465 PATIENTS/ARM). THE MAIN SURGICAL APPARATUS USED IN THIS STUDY IS SHOWED BELOW (FIG. 2): A STORZ LAPAROSCOPIC SURGERY SYSTEM INCLUDES A 5 MM¿30°LAPAROSCOPIC LENS, A VERESS NEEDLE FOR ESTABLISHING CARBON DIOXIDE (CO2) PNEUMOPERITONEUM, A 5 MM TROCAR FOR PUNCTURING PERITONEUM, A 5 ML SYRINGE FOR HYDRO DISSECTION IF NECESSARY, AND A 2¿0 NONABSORBABLE MONOFILAMENT SUTURE (PROLENE, ETHICON LLC, PUERTO RICO, USA) FOR HIGH LIGATION OF THE INGUINAL HERNIA SAC. THE REPORTED COMPLICATIONS INCLUDED SURGICAL SITE INFECTION (N=6), VISIBLE SCAR (N=3), RECURRENCE (N=8), AND POSTOPERATIVE HYDROCELE (N=10). IN CONCLUSION, IN THIS COHORT STUDY, THE MODIFIED NEEDLE GRASPER IS A SAFE AND FEASIBLE INSTRUMENT FOR SLPEC, AND SLPEC USING THE NEEDLE GRASPER HAS A SHORTER OPERATION TIME THAN TLPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64509 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention