BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 9335748 · Received November 18, 2019

    Report

    Report Number
    2210968-2019-90034
    Event Type
    Injury
    Date Received
    November 18, 2019
    Report Date
    October 29, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    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. 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 (BRAIDED SUTURE, PDS II SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS AND PATIENT DEATHS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (BRAIDED SUTURE, PDS II SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS: NO FURTHER INFORMATION WILL BE PROVIDED, BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE CUSTOMER. CITATION: INTERNATIONAL JOURNAL OF SURGERY 11 (2013) 891-897. DOI: HTTP://DX.DOI.ORG/10.1016/J.IJSU.2013.07.012 . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE "TITLE: USEFULNESS OF VESSEL-SEALING DEVICES COMBINED WITH CRUSH CLAMPING METHOD FOR HEPATECTOMY: A RETROSPECTIVE COHORT STUDY" AUTHORS: ATSUSHI NANASHIMA, TAKAFUMI ABO, JUNICHI ARAI, KATSUNORI TAKAGI, HIROFUMI MATSUMOTO, HIROAKI TAKESHITA, TOMOSHI TSUCHIYA, TAKESHI NAGAYASU CITATION: INTERNATIONAL JOURNAL OF SURGERY 11 (2013) 891-897. DOI: HTTP://DX.DOI.ORG/10.1016/J.IJSU.2013.07.012. THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE EFFICACY OF THE VESSEL-SEALING DEVICES FOR CONTROLLING BLOOD LOSS, TRANSECTION TIME AND POSTOPERATIVE COMPLICATIONS IN HEPATECTOMY AS A COHORT STUDY. THIS RETROSPECTIVE STUDY INVOLVES 267 PATIENTS WITH LIVER DISEASE WHO UNDERWENT HEPATIC RESECTION BETWEEN 2005 AND SEPTEMBER 2012. ONE HUNDRED EIGHTEEN PATIENTS UNDERWENT THE CONVENTIONAL CRUSH CLAMPING METHOD BETWEEN 2004 AND 2008 (CONTROL GROUP) AND 149 PATIENTS USED VESSEL SEALING DEVICES BETWEEN 2008 AND 2012 (VS GROUP). OF THE 149 PATIENTS IN THE VS GROUP, 120 PATIENTS (80 MALE AND 40 FEMALE) USED LIGASURE DEVICES AND 29 PATIENTS (20 MALE AND 9 FEMALE) USED HARMONIC FOCUS (ETHICON)(N-24; 15 MALE AND 9 FEMALE) OR HARMONIC ACE(ETHICON) (N-5; 5 MALE; MEAN AGE 58±9 YEARS). IN THE CASE OF OPEN LAPAROTOMY, LARGER VESSELS WERE TIED USING ABSORBABLE BRAID (ETHICON). GLISSONIAN BRANCHES NEAR THE SECONDARY TRUNK WERE ALSO TIED. THE ISOLATED LARGE HEPATIC VEIN WAS LIGATED BY ENDOPATH-ENDOCUTTER ETS-FREX 35 (STAPLE LOAD; 3.0X35 MM, WHITE CARTILAGE; ETHICON). THE HARMONIC FOCUS CURVED SHEARS (ULTRASONIC COAGULATOR DISSECTOR; ETHICON) WAS USED FOR OPEN LAPAROTOMY AND IN LIMITED RESECTION, SEGMENTECTOMY OR SECTIONECTOMY AND IN HEMIHEPATECTOMY OR MORE EXTENDED HEPATECTOMY. A HARMONIC DEVICE GENERATOR 300 SYSTEM (ETHICON) WAS OPERATED USING A HAND SWITCH (ETHICON), AS A FULL FEATURED HIGH-FREQUENCY MECHANICAL ENERGY SYSTEM. ANY BLEEDING SITE AND MACROSCOPICALLY DETECTED BILE LEAKAGE POINTS IN THE CUT PLANE WERE SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE (PDS)-II SUTURE (ETHICON). REPORTED COMPLICATIONS IN THE LIGASURE GROUP DURING LIMITED RESECTION, SEGMENTECTOMY OR SECTIONECTOMY INCLUDED BLOOD LOSS (703±619/560±474) (N-?) IN WHICH 5 PATIENTS RECEIVED RED CELL TRANSFUSION, HEPATECTOMY-RELATED COMPLICATIONS ¿ (N-?), BILE LEAKAGE (N-1) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE, AND INTRAABDOMINAL ABSCESS FORMATION (N-2). REPORTED COMPLICATIONS IN THE LIGASURE GROUP DURING HEMIHEPATECTOMY OR MORE EXTENDED HEPATECTOMY INCLUDED BLOOD LOSS (1029±637/952±567) (N-?) IN WHICH 11 PATIENTS RECEIVED RED CELL TRANSFUSION, HEPATECTOMY-RELATED COMPLICATIONS ¿ (N-?), BILE LEAKAGE (N-2) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE, AND INTRAABDOMINAL ABSCESS FORMATION (N-3). REPORTED COMPLICATIONS IN THE HARMONIC GROUP DURING LIMITED RESECTION, SEGMENTECTOMY OR SECTIONECTOMY INCLUDED BLOOD LOSS (534±445) (N-?), BILE LEAKAGE (N-1) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE. REPORTED COMPLICATIONS IN THE HARMONIC GROUP DURING HEMIHEPATECTOMY OR MORE EXTENDED HEPATECTOMY INCLUDED BLOOD LOSS (1410±1010) (N-?) IN WHICH 4 PATIENTS RECEIVED RED CELL TRANSFUSION HEPATECTOMY-RELATED COMPLICATIONS ¿ (N-?), UNCONTROLLED ASCITES (N-8), BILE LEAKAGE (N-4) WHICH WAS SUTURED USING ABSORBABLE 4-0 MONOFILAMENT POLYDIOXANONE SUTURE, AND INTRAABDOMINAL ABSCESS FORMATION (N-3). IN CONCLUSION, THE LATEST VESSEL SEALER IS VERY USEFUL FOR OPEN AND LAPAROSCOPIC HEPATECTOMY FOR HEPATIC PARENCHYMAL TRANSECTION IN COMPARISON WITH THE CONVENTIONAL PROCEDURE, DUE TO THE MINIMIZATION OF BLOOD LOSS AND THE SHORTENING OF TRANSECTION TIME, RESULTING IN BETTER POSTOPERATIVE OUTCOMES IN HEPATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129299 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention