BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 16929988 · Received May 15, 2023

    Report

    Report Number
    2210968-2023-03579
    Event Type
    Injury
    Date Received
    May 15, 2023
    Date of Event
    January 28, 2022
    Report Date
    May 15, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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. 6. 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 NEUROSURG. (2022) 161:E282-E288; HTTPS://DOI.ORG/10.1016/J.WNEU.2022.01.118. 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: LONG-TERM OUTCOMES OF ENDOSCOPIC CYST FENESTRATION FOR RATHKE CLEFT CYST . AUTHOR(S): HIROKI YAMADA, RYO UEDA, HIROYUKI OZAWA, MASAHIRO TODA . CITATION: WORLD NEUROSURG. (2022) 161:E282-E288; HTTPS://DOI.ORG/10.1016/J.WNEU.2022.01.118 . THE OBJECTIVE OF THE STUDY IS TO ELUCIDATE THE LONG-TERM SURGICAL OUTCOMES AND INCIDENCE OF RECURRENCE AND REOPERATION OF ENDOSCOPIC ENDONASAL CYST FENESTRATION FOR RATHKE CLEFT CYST. BETWEEN JANUARY 2008 AND AUGUST 2021, 27 PATIENTS WITH RATHKE CLEFT CYST WHO WERE TREATED WITH ENDOSCOPIC SURGERY WERE INCLUDED IN THE STUDY. OF THE 27 PATIENTS, 20 (74%) WERE WOMEN. THE PATIENTS' MEAN AGE WAS 45+/-18 YEARS. CYST FENESTRATION WAS PERFORMED IN ALL PATIENTS. IN 2 PATIENTS WITH TUMOR COMPLICATIONS, TUMOR RESECTION WAS ALSO PERFORMED. IF THERE WAS INTRAOPERATIVE CEREBROSPINAL FLUID LEAKAGE, THE SELLA TURCICA WAS PACKED WITH ABDOMINAL FAT OR OXIDIZED REGENERATED CELLULOSE, OR SURGICEL (ETHICON), AND THE SELLAR FLOOR WAS RECONSTRUCTED USING A NASOSEPTAL FULL FLAP MADE FROM THE RESCUE FLAP. IF THERE WAS NO CEREBROSPINAL FLUID LEAKAGE, THE SELLA TURCICA WAS FILLED WITH ABDOMINAL FAT AND RECONSTRUCTION WAS NOT PERFORMED OR WAS PERFORMED USING A NASOSEPTAL FLAP OR FREE MIDDLE TURBINATE MUCOSA, DEPENDING ON THE SURGEON¿S PREFERENCE. IN ADDITION, THERE WERE A FEW PATIENTS IN WHOM THE FASCIA WAS USED OR NON-ETHICON FIBRIN GLUE (MANUFACTURER: UNKNOWN) WAS SOLELY APPLIED. SURGICEL (ETHICON) WAS USED IN 8 PATIENTS WHO HAD NO INTRAOPERATIVE CEREBROSPINAL FLUID LEAKAGE AND IN 5 PATIENTS WHO HAD CEREBROSPINAL FLUID LEAKAGE. PATIENTS STARTED WALKING ON THE DAY AFTER THE SURGERY, AND MOST OF THEM WERE DISCHARGED WITHIN A WEEK. THE REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE CEREBROSPINAL FLUID LEAK (N=1). IN CONCLUSION, PATIENTS WITH A SYMPTOMATIC RATHKE CLEFT CYST CAN BE EFFECTIVELY TREATED WITH ENDOSCOPIC ENDONASAL CYST FENESTRATION. REVERSAL OF THE PRESENTING SYMPTOMS RESULTED, INCLUDING HEADACHE, VISUAL DYSFUNCTION, AND PITUITARY HORMONE DYSFUNCTION, IN THE MAJORITY OF PATIENTS. IN OUR SERIES, APPROPRIATE RECONSTRUCTION OF THE SELLAR FLOOR REDUCED THE RISK OF POSTOPERATIVE CEREBROSPINAL FLUID LEAKAGE WITHOUT IMPACTING CYST REGROWTH. THIS SIMPLE TECHNIQUE APPEARS TO EFFECTIVELY DISRUPT CYST PROGRESSION IN MOST CASES, EVEN AFTER A RELATIVELY LONG-TERM FOLLOW-UP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1351684 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other