BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 8233578 · Received January 10, 2019

    Report

    Report Number
    2210968-2019-78311
    Event Type
    Injury
    Date Received
    January 10, 2019
    Report Date
    December 27, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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 (SILK 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 (SILK SUTURE) USED IN THIS PROCEDURE? CITATION: SURG ENDOSC. 2017; 31: 5159¿5165. DOI: 10.1007/S00464-017-5582-1. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: A COMPARISON BETWEEN TOTALLY LAPAROSCOPIC HYDROCELECTOMY AND SCROTAL INCISION HYDROCELECTOMY WITH LAPAROSCOPIC HIGH LIGATION FOR PEDIATRIC CORD HYDROCELE". AUTHORS: BYUNG SEO CHOI, GEON YOUNG BYUN, SEONG BAE HWANG, BUM HWAN KOO, SUNG RYUL LEE. CITATION: SURG ENDOSC. 2017; 31: 5159¿5165. DOI: 10.1007/S00464-017-5582-1. THE PURPOSE OF THIS STUDY IS TO REPORT CLINICAL CHARACTERISTICS AND TO INVESTIGATE THE FEASIBILITY AND SAFETY OF TOTALLY LAPAROSCOPIC HYDROCELECTOMY (TLH) COMPARED TO SCROTAL INCISION HYDROCELECTOMY WITH LAPAROSCOPIC HIGH LIGATION (SIH) FOR PEDIATRIC CORD HYDROCELE (CH). FROM SEPTEMBER 2011 TO FEBRUARY 2016, A TOTAL OF 490 MALE PATIENTS (AGE RANGE: 1.0 TO 192.0 MONTHS), OF WHICH, 148 PATIENTS UNDERWENT SIH, AND 342 PATIENTS UNDERWENT TLH FOR CH. IN THE SIH PROCEDURE, AFTER THE VISUALIZATION OF THE INTERNAL RING, HIGH LIGATION OF PATENT PROCESSUS VAGINALIS WAS PERFORMED WITH MERSILK 3-0 (ETHICON). IN THE SIH GROUP, REPORTED COMPLICATIONS INCLUDED WOUND HEMATOMA (N-2) AND RECURRENCE APPEARED IN THE COMMUNICATING HYDROCELE (N-1). IT WAS CONCLUDED THAT ALL OF CORD HYDROCELES HAD PPV SO HIGH LIGATION WAS REQUIRED. THE RESULT OF SIH WAS COMPARABLE WITH OTHER LITERATURE. THE RESULT OF TLH WAS ALSO COMPARABLE WITHOUT INCREASED COMPLICATION RATE OR OPERATION TIME EVEN THOUGH THERE WAS NO ADDITIONAL INCISION. TLH FOR UNILATERAL CORD HYDROCELE, IN PARTICULAR, HAD SIGNIFICANTLY SHORTER OPERATION TIME COMPARED TO SIH. HENCE, WHEN PERFORMED BY A SURGEON, WHO IS EXPERT AT LAPAROSCOPIC SURGERY, TLH COULD BE ONE OF THE OPTIONS FOR PEDIATRIC CH, ESPECIALLY FOR MIXED TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27316 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention