BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 21778903 · Received April 4, 2025

    Report

    Report Number
    2210968-2025-03587
    Event Type
    Injury
    Date Received
    April 4, 2025
    Date of Event
    December 3, 2024
    Report Date
    April 8, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? NO. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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: NEUROSURGICAL REVIEW (2024) 47:885 HTTPS://DOI.ORG/10.1007/S10143-024-03132-2. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: QIAO N, LI C, LIU F, RU S, CAO L, LU P, ZHANG Y, GUI S. DEVELOPMENT AND VALIDATION OF A NOMOGRAM FOR PREDICTING CEREBROSPINAL FLUID LEAK AFTER ENDOSCOPIC CRANIOPHARYNGIOMA RESECTION. NEUROSURG REV. 2024 DEC 3;47(1):885. DOI: 10.1007/S10143-024-03132-2. PMID: 39625533. THE AIM OF THIS STUDY IS TO IDENTIFY RISK FACTORS FOR CEREBROSPINAL FLUID (CSF) LEAK AFTER EXTENDED ENDOSCOPIC ENDONASAL SURGERY FOR CRANIOPHARYNGIOMAS AND DEVELOP A PREDICTIVE MODEL FOR PREDICTING POSTOPERATIVE CSF LEAK. BETWEEN OCTOBER 2018 AND MAY 2024, 660 CASES OF CRANIOPHARYNGIOMA (TRAINING COHORT: N=462; VALIDATION COHORT: N=198) WERE RETROSPECTIVELY REVIEWED AND RELEVANT RISK FACTORS WERE IDENTIFIED. INCLUSION CRITERIA INCLUDED: 1) ADULT, 2) UNDERWENT EXTENDED ENDOSCOPIC ENDONASAL APPROACH (EEEA), 3) HIGH-FLOW INTRAOPERATIVE CSF LEAKS [36], 4) HISTOPATHOLOGICALLY CONFIRMED CRANIOPHARYNGIOMA, AND 5) AVAILABILITY OF INTACT MEDICAL RECORDS. EXCLUSION CRITERIA INCLUDED: 1) ABSENCE OF THREE-DIMENSIONAL COMPUTED TOMOGRAPHY (3D-CT), 2) FAILURE TO THE FOLLOW-UP EVALUATION OF CSF LEAK AFTER SURGERY, AND 3) INCOMPLETE MEDICAL RECORDS. ADDITIONALLY, THERE WERE ONLY SEVEN CASES OF CONCHAL-TYPE SPHENOID SINUS IN OUR COHORT, WHICH WERE EXCLUDED FROM THE ANALYSIS. ULTIMATELY, 660 OF 862 CASES (76.6%) SATISFIED THE CRITERIA AND WERE INCORPORATED INTO THE FINAL ANALYSIS. ALL CASES WERE RANDOMLY DISTRIBUTED TO THE TRAINING AND VALIDATION GROUPS AT A 7:3 RATIO (FIG. 1). AFTER THE TUMOR WAS REMOVED, RECONSTRUCTION OF THE SKULL BASE WAS PERFORMED. THE INITIAL LAYER UTILIZED ARTIFICIAL DURA (TIANXINFU, BEIJING), WHICH WAS CUT LARGER THAN THE DEFECTS IN THE DURA AND POSITIONED INTRADURALLY TO REDUCE THE IMPACT OF CEREBROSPINAL FLUID ON THE GRAFT MATERIALS. THREE TECHNIQUES FOR RECONSTRUCTION WERE EMPLOYED IN THE SECOND LAYER [13]: 1) IN THE MAJORITY OF INSTANCES, THE NSF ALONE WAS SUFFICIENT; 2) FOR LARGE DURAL DEFECTS OR COMPROMISED NSFS, AUTOLOGOUS FASCIA LATA AND FAT WAS USED AS WELL AS THE NSF. IF THE NSF HAD BEEN PREVIOUSLY UTILIZED IN EARLIER SURGERIES, IT WAS REUSED IF STILL VIABLE; 3) IN CASES WHERE THE NSF WAS NOT A FEASIBLE OPTION, RECONSTRUCTION UTILIZING ARTIFICIAL DURA AND FREE TISSUE GRAFTS (E.G., FASCIA LATA AND FAT) WAS EXCLUSIVELY PERFORMED. IN THE THIRD LAYER, THE EDGES OF THE FLAP WERE TREATED WITH OXIDIZED CELLULOSE (SURGICEL, JOHNSON & JOHNSON, USA) AND PORCINE FIBRIN SEALANT TO INHIBIT MIGRATION. FOR APPROXIMATELY TWO WEEKS, IODOFORM GAUZE OR EXPANDABLE SPONGE PACKING PROVIDED SUPPORT TO THE NSF. REPORTED COMPLICATIONS ARE THE FOLLOWING: POSTOPERATIVE CEREBROSPINAL FLUID (CSF) LEAKS (N=?). TREATMENT: NOT REPORTED. DEVELOPED A CEREBROSPINAL FLUID (CSF) LEAK (N=1; 33 YEAR OLD, FEMALE PATIENT). TREATMENT: UNDERWENT SUCCESSFUL REPAIR. IN CONCLUSION, HIGHER PNI LEVELS MAY HELP REDUCE THE RISK OF POSTOPERATIVE CSF LEAK, WHILE A LARGER DURAL DEFECT SIZE WAS DEMONSTRATED AS AN INDEPENDENT RISK FACTOR. WE DEVELOPED AND VALIDATED A NOMOGRAM FOR PREDICTING CSF LEAK AFTER ENDOSCOPIC CRANIOPHARYNGIOMA RESECTION, WHICH SHOWED STRONG PREDICTIVE PERFORMANCE AND COULD ASSIST CLINICIANS IN FORMULATING PERSONALIZED TREATMENT STRATEGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048773 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention