BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7855956 · Received September 7, 2018

    Report

    Report Number
    2210968-2018-75705
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 23, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS 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. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (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 PRODUCT(VICRYL SUTURE)S USED IN THIS PROCEDURE? CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2014; 21: 650¿655. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: "COMPARISON OF THE USE OF LIGASURE, HALO PKS CUTTING FORCEPS, AND ENSEAL TISSUE SEALER IN TOTAL LAPAROSCOPIC HYSTERECTOMY: A RANDOMIZED TRIAL". AUTHORS: HAKAN AYTAN, MD*, HAKAN NAZIK, MD, RAZIYE NARIN, MD, MURAT API, MD, AND EKREM C. TOK, MD. CITATION: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. 2014; 21: 650¿655. DOI: HTTP://DX.DOI.ORG/10.1016/J.JMIG.2014.01.010. THERE ARE MANY INSTRUMENTS WITH DIFFERENT ENERGY MODALITIES OR WITH DIFFERENT PROPERTIES THAT ARE AVAILABLE FOR USE IN TOTAL LAPAROSCOPIC HYSTERECTOMY. THE AIM OF THIS RANDOMIZED PROSPECTIVE STUDY WAS TO COMPARE THE USE OF LIGASURE (15 PATIENTS; AGE: 48.6 ± 6.4; BMI: 31.1 ± 4.9), HALO PKS CUTTING FORCEPS (15 PATIENTS; AGE: 50.2 ± 8.7; BMI: 29.7 ± 5.6), AND ENSEAL TISSUE SEALER (ETHICON; 15 PATIENTS; AGE: 51.2 ± 7.4; BMI: 30.7 ± 4.2) IN TOTAL LAPAROSCOPIC HYSTERECTOMY WITH RESPECT TO OPERATION TIME AND BLOOD LOSS AS MAIN OUTCOMES. A TOTAL OF 45 PATIENTS WITH THE INDICATION OF HYSTERECTOMY WERE RANDOMIZED INTO 3 GROUPS FOR TOTAL LAPAROSCOPIC HYSTERECTOMY. DURING THE PROCEDURE, THE UTEROVESICAL PERITONEUM WAS INCISED. THE UTERINE ARTERIES WERE IDENTIFIED AND TRANSECTED. ALL THESE STEPS WERE PERFORMED USING LIGA-SURE, HALO PKS, OR ENSEAL TISSUE SEALER (ETHICON). IN ALL GROUPS, THE VAGINAL VAULT WAS CLOSED LAPAROSCOPICALLY WITH CONTINUOUS SUTURING BY USING VICRYL 1-0 SUTURE (ETHICON). IN THE ENSEAL GROUP, REPORTED COMPLICATIONS INCLUDED BLEEDING (N-2) WHICH REQUIRED CONVENTIONAL BIPOLAR ELECTROSURGERY TO CONTROL THE BLEEDING AND BLADDER INJURY (N-1) WHICH WAS SUTURED LAPAROSCOPICALLY. IN CONCLUSION, THE DATA INDICATE THAT THE 3 BIPOLAR PLATFORMS SHOWED SIMILAR PERFORMANCES IN TLH. THESE INSTRUMENTS WERE NOT DETERMINED TO BE INDEPENDENT PREDICTORS OF OPERATING TIME AND AMOUNT OF BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695223 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention