BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9628495 · Received January 24, 2020

    Report

    Report Number
    2210968-2020-00683
    Event Type
    Injury
    Date Received
    January 24, 2020
    Report Date
    January 8, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. RESPONSE: NO FURTHER INFORMATION WILL BE PROVIDED, CITATION: UPDATES SURG (2017) 69:55¿60; DOI: 10.1007/S13304-016-0412-X . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: ULTRASONIC ENERGY DEVICE VERSUS MONOPOLAR ENERGY DEVICE IN LAPAROSCOPIC TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA REPAIR" AUTHORS: SHIMPEI OTSUKA; YUJI KANEOKA; ATSUYUKI MAEDA; YUICHI TAKAYAMA; YASUYUKI FUKAMI; SHUNSUKE ONOE CITATION: UPDATES SURG (2017) 69:55¿60; DOI: 10.1007/S13304-016-0412-X. THIS RETROSPECTIVE STUDY DESCRIBED THE TRANSABDOMINAL PREPERITONEAL (TAPP) REPAIR PROCEDURE AND REPORT THE RESULTS OF A COMPARATIVE STUDY CONDUCTED TO DETERMINE WHETHER THE ULTRASONIC ENERGY DEVICE IS EVEN NECESSARY. BETWEEN NOVEMBER 2012 AND DECEMBER 2014, 241 PATIENTS UNDERWENT TAPP REPAIR FOR INGUINAL HERNIA IN WHICH THE PATIENTS WERE DIVIDED INTO TWO GROUPS: ULTRASONIC ENERGY DEVICE (U GROUP) (MALE=114, FEMALE=15; AGE RANGE=61.1 ± 1.2 YEARS; BMI RANGE 23.0 ± 0.3 KG/M^2) AND MONOPOLAR ENERGY DEVICE (M GROUP) (MALE=123, FEMALE=17; AGE RANGE=61.9 ± 1.1 YEARS; BMI RANGE 23.2 ± 0.3 KG/M^2). HARMONIC ACE (ETHICON) WAS USED IN THE PROCEDURE. THE PERITONEAL DEFECT WAS THEN CLOSED WITH A CONTINUOUS 3-0 VICRYL SUTURE (ETHICON). REPORTED COMPLICATION INCLUDED SEROMA (N=4) WHICH HAD RESOLVED SPONTANEOUSLY OR WITH A ONE-TIME PUNCTURE; FUNICULITIS (N=1) WHICH RESOLVED WITH ANTIBIOTIC THERAPY. IN CONCLUSION, INCREASED COMPETENCE WITH MONOPOLAR ENERGY DEVICE LEAD TO CONCLUDE THAT THE ULTRASONIC ENERGY DEVICE IS UNNECESSARY FOR SIMPLE TAPP REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88483 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention