BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9334928 · Received November 18, 2019

    Report

    Report Number
    2210968-2019-90026
    Event Type
    Injury
    Date Received
    November 18, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 PATIENT EVENTS. 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. 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 PRODUCT (VICRYL OR PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (BLOOD LOSS, INFECTION) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCT (VICRYL OR PROLENE SUTURE INVOLVED? WHAT IS THE SPECIFIC NUMBER OF PATIENTS WHO HAD EVENT OF INFECTION, BLEEDING WITH THE USE OF ETHICON SUTURE (VICRYL OR PROLENE)? CITATION: SURG ENDOSC (2016) 30:1004¿1013; DOI 10.1007/S00464-015-4284-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: ROBOTIC VERSUS LAPAROSCOPIC RESECTIONS OF POSTEROSUPERIOR SEGMENTS OF THE LIVER: A PROPENSITY SCORE-MATCHED COMPARISON" AUTHORS: ROBERTO MONTALTI; VINCENZO SCUDERI; ALBERTO PATRITI; MARCO VIVARELLI; ROBERTO I. TROISI. CITATION: SURG ENDOSC (2016) 30:1004¿1013; DOI 10.1007/S00464-015-4284-9. THE AIM OF THIS PROSPECTIVE STUDY WAS TO COMPARE MINOR ROBOTIC LIVER RESECTIONS TO LAPAROSCOPIC LIVER RESECTIONS FOR TUMORS LOCATED IN POSTEROSUPERIOR (PS) SEGMENTS IN A 2:1 CASE¿CONTROL STUDY MATCHED BY PROPENSITY SCORE ANALYSIS IN ORDER TO INVESTIGATE INTRA- AND POSTOPERATIVE OUTCOMES OF THE TWO TECHNIQUES IN CONDITIONS WHERE PARENCHYMAL-PRESERVING RESECTIONS WERE PERFORMED. BETWEEN JUNE 2008 AND FEBRUARY 2014, 36 PATIENTS (MALE=21; MEAN AGE=62 ± 13 YEARS, AGE RANGE=32-84 YEARS) UNDERWENT ROBOT-ASSISTED LIVER RESECTION WERE MATCHED WITH 72 PATIENTS (MALE=39; MEAN AGE=56.8 ± 15 YEARS, AGE RANGE=17-79 YEARS) UNDERGOING LAPAROSCOPIC LIVER RESECTION. IN ROBOTIC LIVER RESECTIONS GROUP, HEMOSTASIS OF SMALL VESSELS WAS OBTAINED USING A MONOPOLAR OR BIPOLAR CAUTERY. TO SECURE LARGER VESSELS ON THE TRANSECTION LINE, HEM-O-LOCK CLIPS OR LIGATURES WITH VICRYL OR PROLENE (ETHICON) WERE USED. THE HEPATIC VEINS WERE USUALLY DIVIDED WITH A LAPAROSCOPIC LINEAR STAPLER (ENDOGIA, ETHICON) OR SUTURED. IN LAPAROSCOPIC LIVER RESECTION GROUP, PARENCHYMA DIVISION WAS PERFORMED USING SURGICAL ASPIRATOR AND A HARMONIC SCALPEL (ETHICON) FOR THE GLISSONIAN APPROACH. LARGER VASCULAR/BILIARY STRUCTURES WERE CONTROLLED WITH THE ENDOCLIPS OR VASCULAR STAPLERS (ENDOGIA, ETHICON; TRI-STAPLER TECHNOLOGY, COVIDIEN). REPORTED COMPLICATIONS IN ROBOTIC LIVER RESECTIONS GROUP INCLUDED INFECTION [PROLENE OR VICRYL (N=?), ENDOGIA (N=?)], BILIARY LEAK [ENDOGIA (N=?)]; FLUID COLLECTIONS [ENDOGIA (N=?)]; VCI SYNDROME [ENDOGIA (N=1)]; BLEEDING [ENDOGIA (N=?)]. REPORTED COMPLICATIONS LAPAROSCOPIC LIVER RESECTION GROUP INCLUDED INFECTION [ENDOGIA (N=?]; BILIARY LEAK [ENDOGIA (N=?)]; BLEEDING [ENDOGIA (N=?)]; FLUID COLLECTIONS [ENDOGIA (N=?)]; PERIOPERATIVE BLOOD LOSS [HARMONIC SCALPEL (N=?)]. IN CONCLUSION, ROBOT-ASSISTED RESECTIONS IN THE PS SEGMENTS ARE COMPARABLE IN SAFETY AND FEASIBILITY TO PURE LLR IN A HIGH-VOLUME CENTER, ALTHOUGH A TREND TO A HIGHER DEGREE OF COMPLICATIONS WAS RECORDED WITH THE ROBOTIC TECHNIQUE. HOWEVER, BASED ON OUR RESULTS USING PROPENSITY MATCHING, THE CLAIMED SUPERIORITY OF ROBOTICS OVER THE LAPAROSCOPIC APPROACH HAS NOT BEEN PROVEN FOR PS SEGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1133315 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention