BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 17995354 · Received October 24, 2023

    Report

    Report Number
    2210968-2023-08096
    Event Type
    Injury
    Date Received
    October 24, 2023
    Date of Event
    June 29, 2023
    Report Date
    October 24, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 4. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 5. 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: J. CLIN. MED. 2023;12(4384):1-11. HTTPS://DOI.ORG/10.3390/JCM12134384. 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: IMPACT OF CURRENT TECHNOLOGY IN LAPAROSCOPIC ADRENALECTOMY: 20 YEARS OF EXPERIENCE IN THE TREATMENT OF 254 CONSECUTIVE CLINICAL CASES AUTHORS: GIOVANNI CONZO 1,*, RENATO PATRONE 2,3 , LUIGI FLAGIELLO 1, ANTONIO CATAURO 1, ALESSANDRA CONZO 1, CHIARA CACCIATORE 1, FEDERICO MARIA MONGARDINI 1 , GIOVANNI COZZOLINO 1, ROSETTA ESPOSITO 1, DANIELA PASQUALI 4, GIUSEPPE BELLASTELLA 5 , KATHERINE ESPOSITO 6 AND LUDOVICO DOCIMO 1 CITATION: J. CLIN. MED. 2023;12(4384):1-11. HTTPS://DOI.ORG/10.3390/JCM12134384. THE AIM OF THIS RETROSPECTIVE STUDY IS TO ASSESS TECHNIQUE SAFETY, PATIENT OUTCOMES AND THE IMPACT OF NEW SURGICAL TOOLS. BETWEEN JANUARY 2003 AND DECEMBER 2022, A TOTAL OF 254 PATIENTS [103 MALE AND 151 FEMALE; AVERAGE AGE WAS 53.2 YEARS (RANGE 22¿79)] WHO UNDERWENT LAPAROSCOPIC ADRENALECTOMY (LA) IN THE TREATMENT OF ADRENAL NEOPLASM WERE INCLUDED IN THE STUDY. DURING THE FIRST YEARS OF EXPERIENCE, A MONOPOLAR HOOK WAS UTILIZED. SUCCESSIVELY, A HARMONIC SCALPEL (HS) (ETHICON ENDOSURGERY, INC., CINCINNATI, OH, USA), LIGASURE VESSEL SEALING SYSTEM (LS) (TYCO VALLEYLAB, BOULDER, 20052 MONZA, ITALY) AND THUNDERBEAT (TB) (OLYMPUS EUROPA SE & CO., HAMBURG, GERMANY) WERE UTILIZED AS ADVANCED HEMOSTASIS DEVICES, ABLE TO SEAL AND CUT VESSELS WITH THE APPLICATION OF DIFFERENT MODALITIES OF ENERGY (RADIOFREQUENCY, ULTRASOUND OR BOTH). FIBRIN SEALENT TISSUCOL¿TESSEEL (BAXTER, DEERFIELD, IL, USA), FLOSEAL HEMOSTATIC MATRIX (BAXTER), HEMOPATCH® (BAXTER) AND TABOTAMP® WERE ALSO SELECTIVELY UTILIZED TO ACHIEVE A BETTER HEMOSTATIC CONTROL. THE MEAN FOLLOW-UP PERIOD WAS 43.52 MONTHS (4¿150). REPORTED COMPLICATIONS INCLUDE ABDOMINAL WALL HEMATOMAS (N=?) AND INFECTION OF THE SURGICAL SITE (N=?). IN CONCLUSION, LA IS A SAFE PROCEDURE, EVEN FOR MASSES LARGER THAN 6 CM AND PCCS. UNDOUBTEDLY, THE DEVELOPMENT OF SURGICAL TECHNOLOGY HAS MADE IT POSSIBLE REDUCING OPERATIVE TIMES, PERFORMING A ¿CLIPLESS¿ ADRENALECTOMY AND EXTENDING THE INDICATIONS IN THE TREATMENT OF MORE COMPLEX PATIENTS. A MULTIDISCIPLINARY TEAM, IN REFERRAL HIGH-VOLUME CENTERS, IS RECOMMENDED IN THE MANAGEMENT OF ADRENAL PATHOLOGY. A 30-PROCEDURE LEARNING CURVE IS NECESSARY TO IMPROVE SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277136 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other