BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 12492650 · Received September 17, 2021

    Report

    Report Number
    2210968-2021-08636
    Event Type
    Injury
    Date Received
    September 17, 2021
    Date of Event
    July 23, 2020
    Report Date
    August 24, 2021
    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 · 1

    PRODUCT COMPLAINT # (B)(4). COMPONENT CODE: (B)(4) 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? CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED IN EACH PROCEDURE? CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; 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 (2021) 44:1635¿1643, HTTPS://DOI.ORG/10.1007/S10143-020-01351-X. EVENT RELATED TO MW # 2210968-2021-08633, MW # 2210968-2021-08634. 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 · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: OPTIMAL SURGICAL INDICATIONS OF ENDOSCOPIC SURGERY FOR TRAUMATIC ACUTE SUBDURAL HEMATOMA IN ELDERLY PATIENTS BASED ON A SINGLE-INSTITUTION EXPERIENCE. AUTHORS: KOICHI MIKI, MASANI NONAKA, HIROMASA KOBAYASHI, YOSHINOBU HORIO, HIROSHI ABE, TAKASHI MORISHITA, MITSUTOSHI IWAASA, TOORU INOUE. CITATION:NEUROSURGICAL REVIEW (2021) 44:1635¿1643, HTTPS://DOI.ORG/10.1007/S10143-020-01351-X. IN THIS RETROSPECTIVELY STUDY THE AUTHORS REVIEWED THE CASES OF 26 PATIENTS UNDERWENT ENDOSCOPIC SURGERY PATIENTS OLDER THAN 65 YEARS OF AGE WHO UNDERWENT PATIENTS SELECTED FOR ENDOSCOPIC SURGER (ES) AMONG ELDERLY PATIENTS WITH ACUTE SUBDURAL HEMATOMA (ASDH) AND INVESTIGATED THE EFFICACY AND SAFETY OF THIS PROCEDURE IN RELATION TO THESE PARAMETERS WITHIN THE PERIOD BETWEEN JANUARY 2011 AND MARCH 2019 AT FUKUOKA UNIVERSITY HOSPITAL. ASDH WAS DEFINED AS A SUBDURAL HEMATOMA < 4 DAYS FROM ONSET. ALL ENDOSCOPIC SURGERIES WERE PERFORMED UNDER GENERAL ANESTHESIA. A 4¿5-CM STRAIGHT SKIN INCISION WAS MADE, AND 3 × 4 CM SMALL CRANIOTOMY CREATED AT THE THICKEST POINT OF THE HEMATOMA THE SURGEONS OCCASIONALLY BENT AND FURTHER INSERTED THE SUCTION TUBE IN ORDER TO REACH THE PARTS OF THE HEMATOMA MOST DISTAL TO THE SMALL CRANIOTOMY. IF THE BLEEDING POINT WAS IDENTIFIED, IT WAS TREATED BY BIPOLAR OR MONOPOLAR COAGULATION USING ELECTROCOAGULATION WITH AN ASPIRATION TUBE AND COVERED WITH PIECES OF ABSORBABLE FIBRILLAR¿ HEMOSTAT (SURGICEL®; ETHICON, TOKYO, JAPAN). REPORTED COMPLICATIONS INCLUDED CORTICAL ARTERY (N=12), CONTUSION (N=5), BRIDGING VEIN (N=2), BRIDGING VEIN AND CONTUSION (N=1). PROGRESSION OF INTRAPARENCHYMAL HEMATOMA (N=7). AN 86-YEAR-OLD MAN PROGRESSION OF INTRAPARENCHYMAL HEMATOMA. A 65-YEAR-OLD WOMAN WITH RECURRENCE OF ACUTE SUBDURAL HEMATOMA POST-OPERATIVE DAY 1, AND REOPERATION WAS REQUIRED ON THE SAME DAY. IN CONCLUSION ENDOSCOPIC SURGERY MAY BE AN EFFICIENT AND SAFE PROCEDURE FOR TRAUMATIC ASDH IN SELECT ELDERLY PATIENTS. HOWEVER, TREATMENT BY ES IS NOT RECOMMENDED IN PATIENTS WITH A LARGE IPH ON INITIAL CT SCAN. ADDITIONALLY, CLINICIANS SHOULD ALSO BE AWARE THAT ES MUST BE CAREFULLY CONSIDERED IN CASES WITH THE FOLLOWING FACTORS, WHICH MAY INCREASE THE RISK OF IPH PROGRESSION AFTER SURGERY: INJURY IN THE HYPERACUTE PHASE, EXTENT OF MIDLINE SHIFT GREATER THAN SDH THICKNESS, PRESENCE OF A SKULL FRACTURE, AND/OR SAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1390059 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention