BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 17119976 · Received June 13, 2023

    Report

    Report Number
    2210968-2023-04285
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    September 21, 2022
    Report Date
    June 13, 2023
    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 · 0

    PRODUCT COMPLAINT # : (B)(4) THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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. 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 3. WHAT ARE THE PRODUCT CODE AND LOT NUMBER OF THE SURGIFLO DEVICE USED? 4. DOES THE SURGEON BELIEVE THAT THE SURGIFLO PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO ANY ADVERSE EVENTS? 5. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 6. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 7. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 8. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? CITATION: WORLD J SURG (2022); 46:2963¿2972. HTTPS://DOI.ORG/10.1007/S00268-022-06734-3. EVENT RELATED TO MW # 2210968-2023-04284 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: A COMPARATIVE STUDY OF AN INTEGRATED ULTRASONIC/BIPOLAR SEALING DEVICE VERSUS AN ARTICULATING BIPOLAR SEALING DEVICE FOR LAPAROSCOPIC LIVER SURGERY AUTHORS: AN-LIES PROVOOST1 ¿ MATHIEU D¿HONDT1 ¿ EDWARD WILLEMS2 ¿ CELINE DE MEYERE1 : ISABELLE PARMENTIER3 , ANNE DEVOOGHT1 ,HANS POTTEL4 , CHRIS VERSLYPE5 CITATION: WORLD J SURG (2022); 46:2963¿2972. HTTPS://DOI.ORG/10.1007/S00268-022-06734-3. THE AIM OF THIS RETROSPECTIVE STUDY OF A PROSPECTIVELY MAINTAINED DATABASE IS TO COMPARE AN INTEGRATED ULTRASONIC/BIPOLAR SEALING DEVICES (SD) VERSUS AN ARTICULATING BIPOLAR SD IN LAPAROSCOPIC LIVER SURGERY (LLS). BETWEEN (B)(6) 2013 TO (B)(6) 2020, A TOTAL OF 352 PATIENTS WERE INCLUDED IN THE STUDY: TB (N=105; 64 MALE AND 41 FEMALE; MEDIAN AGE OF 64 [55¿72] YEARS; MEDIAN BMI OF 26.0 [22.6¿29.5]) AND ES (N=247; 142 MALE AND 105 FEMALE; MEDIAN AGE OF 64 [56¿74] YEARS; MEDIAN BMI OF 25.7 [23.2¿29.4]). THE THUNDERBEAT (TB) (OLYMPUS EUROPA SE & CO, HAMBURG, GERMANY) WAS USED IN TB GROUP WHILE ENSEAL (ES) (ETHICON ENDO-SURGERY INC., CINCINNATI, USA) WAS USED IN ES GROUP, OF WHICH WERE USED FOR PARENCHYMAL TRANSECTION. THE SD WERE USED IN COMBINATION WITH CUSA (CUSA, PLAINSBORO, USA). THE MONOPOLAR ELECTROCAUTERY AND BIPOLAR FORCEPS WERE USED FOR ADDITIONAL TRANSECTION AND HEMOSTASIS. METAL CLIPS AND LOCKING POLYMER CLIPS (HEM-O-LOK, WECK SURGICAL INSTRUMENTS, TELEFLEX MEDICAL, DURHAM, USA) WERE APPLIED ON SMALL VESSELS AND BILE DUCTS. ENDOVASCULAR STAPLERS (ENDO-GIA, MEDTRONIC, MINNEAPOLIS, USA) WERE USED FOR HEPATIC VEINS AND LARGE PORTAL PEDICLES. BLEEDING FROM INTRAHEPATIC VESSELS WAS HANDLED BY ABSORBABLE MULTIFILAMENT SUTURES (VICRYL, ETHICON, LIVINGSTONE, UK) OR BARBED SYNTHETIC ABSORBABLE MONOFILAMENT SUTURES (FILBLOC, ASSUT EUROPE S.P.A., ROME, ITALY). HEMOSTATIC AGENTS CONSISTED OF FIBRILLAR ABSORBABLE HAEMOSTAT (SURGICEL FIBRILLARTM, ETHICON, BRIDGEWATER, USA), FIBRIN SEALANT PATCH (TACHOSIL, ETHICON, BRIDGEWATER, USA), OR FIBRIN GLUE (TISSEEL, BAXTER INTERNATIONAL, DEERFIELD, USA), WHICH WERE APPLIED ON BROAD SURFACES OF DIFFUSE OOZING OR IN EXPECTED BLEEDING SITES. A HEMOSTATIC MATRIX (SURGIFLO, ETHICON, BRIDGEWATER, USA) WAS USED FOR AGGRESSIVE BLEEDING IN A LOCALIZED SITE. REPORTED COMPLICATIONS INCLUDE POSTOPERATIVE BLEEDING (N=3). IN CONCLUSION, THE INTEGRATED ULTRASONIC/BIPOLAR SD IS SUPERIOR TO THE ARTICULATING BIPOLAR SD IN LLS FOR INTRAOPERATIVE BL WITHOUT AN INCREASE IN COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2215200 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention