BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 16895698 · Received May 9, 2023

    Report

    Report Number
    2210968-2023-03463
    Event Type
    Injury
    Date Received
    May 9, 2023
    Date of Event
    May 1, 2021
    Report Date
    May 9, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. H 6. HEALTH EFFECT - CLINICAL CODE: E2401 - VENTRICULAR PNEUMOCEPHALY. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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: INDIAN J NEUROSURG 2023;12:47¿50; DOI HTTPS://DOI.ORG/10.1055/S-0042-1742475. 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: SELLAR FLOOR RECONSTRUCTION WITH AND WITHOUT INTRASELLAR FAT PACKING AFTER ENDOSCOPIC RESECTION OF LARGE PITUITARY MACROADENOMAS WITH EVIDENT INTRAOPERATIVE CSF LEAK . AUTHOR(S): MOHAB DARWISH, WALID NANOUS, KHALAF HAMEAD, MOSTAFA ISMAIL . CITATION: INDIAN J NEUROSURG 2023;12:47¿50; DOI HTTPS://DOI.ORG/10.1055/S-0042-1742475 . THE STUDY IS AIMED AT EVALUATION OF TIGHT SELLAR FLOOR RECONSTRUCTION WITH AND WITHOUT SELLAR CAVITY FAT PACKING AFTER RESECTION OF PITUITARY ADENOMAS IN PATIENTS WITH EVIDENT INTRAOPERATIVE CEREBROSPINAL FLUID LEAK. FROM JANUARY 2015 TO DECEMBER 2019, 33 PATIENTS WITH EVIDENT INTRAOPERATIVE CEREBROSPINAL FLUID LEAK DURING ENDOSCOPIC RESECTION OF PITUITARY ADENOMAS WERE INCLUDED IN THE STUDY. ALL PATIENTS UNDERWENT ENDOSCOPIC RESECTION OF PITUITARY ADENOMAS PROCEDURE. INITIALLY, 15 PATIENTS (GROUP A) WITH EVIDENT INTRAOPERATIVE ¿LOW FLOW¿ CEREBROSPINAL FLUID LEAK UNDERWENT PACKING OF THE SELLAR CAVITY WITH COMBINED FAT GRAFT AND BIOABSORBABLE MATERIALS USING SURGICEL FIBRILLAR (ETHICON) OR A COMPETITOR GELFOAM (PFIZER). ENCOURAGED BY POSITIVE POSTOPERATIVE RESULTS, THE PACKING OF THE SELLAR CAVITY WAS SHIFTED TO ONLY BIOABSORBABLE MATERIALS IN 18 PATIENTS (GROUP B), EVEN IN PATIENTS WITH INTENTIONAL OPENING OF THE DIAPHRAGMA SELLAE DURING RESECTION OF LARGE ADENOMAS WITH SUPRASELLAR EXTENSION. FOR PATIENTS WITH ¿HIGH-FLOW¿ CEREBROSPINAL FLUID LEAK AND/OR ARACHNOID OPENING LARGER THAN 5MM (8 PATIENTS), ONLY VASCULARIZED NASOSEPTAL WAS USED (8 PATIENTS). THE REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE CEREBROSPINAL FLUID LEAK (N=3) AND A PATIENT WITH CEREBROSPINAL FLUID LEAK, VENTRICULAR PNEUMOCEPHALY AND MENINGITIS (N=1). IN CONCLUSION, THERE IS NO DIFFERENCE IN THE INCIDENCE OF POSTOPERATIVE CEREBROSPINAL FLUID LEAK AND CLINICAL SYMPTOMATIC EMPTY SELLA SYNDROME AMONG BOTH GROUPS, INDICATING THAT TIGHT SELLAR FLOOR REPAIR IS MORE IMPORTANT THAN PACKING THE SELLAR CAVITY WITH OR WITHOUT FAT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1854315 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention