BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 15271218 · Received August 22, 2022

    Report

    Report Number
    2210968-2022-06810
    Event Type
    Injury
    Date Received
    August 22, 2022
    Date of Event
    June 15, 2021
    Report Date
    August 22, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. (B)(4). THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-06811. CITATION: HTTPS://DOI.ORG/10.1007/S00595-021-02314-5.

    Description of Event or Problem · 0

    TITLE: RELATIONSHIP BETWEEN HEPATIC VENOUS ANATOMY AND HEPATIC VENOUS BLOOD LOSS DURING HEPATECTOMY. THE AIM OF THIS RETROSPECTIVE STUDY IS TO CLARIFY THE CLINICAL SIGNIFICANCE OF THE ANATOMICAL INTERVASCULAR RELATIONSHIP OF THE HEPATIC VENOUS FLOW LEADING TO BLOOD LOSS. A TOTAL OF 63 PATIENTS WHO UNDERWENT ANATOMICAL HEPATECTOMY WIDELY EXPOSING THE HEPATIC TRUNK DURING HEMIHEPATECTOMY, CENTRAL SECTIONECTOMY, AND POSTERIOR SECTIONECTOMY BETWEEN APRIL 2014 AND MARCH 2020 WERE INCLUDED. THE PROCEDURE INCLUDED THE ROUTINE CLAMPING OF THE HEPATODUODENAL LIGAMENT TO OCCLUDE TOTAL INFLOW TO THE LIVER DURING TRANSECTION AND THE USE OF THE FORCEPS CLAMP CRUSHING METHOD AND AN ULTRASONIC DISSECTOR AROUND THE MAJOR VESSELS. USING A KELLY CLAMP, THE HEPATIC PARENCHYMA WAS GENTLY CRUSHED, AND CONFIRMATION WAS OBTAINED THAT THE REMNANT VESSELS AND TINY VESSELS (= 2 MM IN DIAMETER) WERE DIVIDED BY THE VESSEL SEALERS. LARGER VESSELS (= 3 MM IN DIAMETER) WERE TIED USING ABSORBABLE BRAID (ETHICON, SOMERVILLE, NJ) OR SILK. GLISSONIAN BRANCHES NEAR THE SECONDARY TRUNK WERE ALSO TIED. THE ISOLATED LARGE HEPATIC VEIN (HV) WAS LIGATED USING VARIOUS VASCULAR STAPLERS. THE SURGICAL HEMOSTATIC DEVICES USED IN THIS SERIES WERE THOSE OF THE LIGASURE¿ SYSTEM (SURGICAL SOLUTIONS GROUP, BOULDER, CO): SEALED VESSELS WERE CUT USING FINE SCISSORS. THE HARMONIC FOCUS® CURVED SHEARS WAS USED AS ANOTHER TYPE OF VESSEL SEALER (ULTRASONIC COAGULATOR DISSECTOR; ETHICON ENDO-SURGERY); THIS DEVICE HAS AN AUTOMATIC CUTTING FUNCTION DURING COAGULATION. AGAIN, THE SEALING TIME WAS A FEW SECONDS. ANY BLEEDING SITES OR MACROSCOPICALLY DETECTED BILE LEAKAGE POINTS IN THE CUT PLANE WERE SUTURED USING ABSORBABLE 4¿0 MONOFILAMENT POLYDIOXANONE (PDS)-II SUTURES (ETHICON). PIN HOLE BLEEDING ALONG THE HV AND OOZING AT THE LIVER PARENCHYMA WERE BURNED BY THE SOFT-COAGULATION ELECTRODE USED WITH THE VIO 300 D ELECTROSURGICAL GENERATOR (ERBE ELEKTROMEDIZIN GMBH) WITH A MONOPOLAR, REUSABLE ELECTRODE WITH A ROUND TIP. THIS HEMOSTATIC SEALING DEVICE WAS MAINLY USED BEFORE MARCH 2016. REPORTED COMPLICATIONS INCLUDE MASSIVE BLEEDING (N=?) REQUIRING INFERIOR VENA CAVA PARTIAL CLAMPING, UNKNOWN EVENT REQUIRING BLOOD TRANSFUSION (N=?), HEPATIC FAILURE (N=?), PERIHEPATIC ABSCESS FORMATION (N=?), UNCONTROLLED ABDOMINAL-PLEURAL EFFUSION (N=?), MILD BILE LEAKAGE (N=?). IN CONCLUSION, THE IVC-RA GAP MIGHT BE A PROMISING NOVEL PREDICTIVE PARAMETER REFLECTING INCREASED BLOOD LOSS LEADING TO BLOOD TRANSFUSION IN ANATOMICAL HEPATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2459643 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention