BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSS UNKNOWN

    MDR report key: 18063779 · Received November 3, 2023

    Report

    Report Number
    1625507-2023-00270
    Event Type
    Injury
    Date Received
    November 3, 2023
    Date of Event
    June 22, 2023
    Report Date
    November 3, 2023
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. B3: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SHUNYA HANAKITA, MD, PHD, MASAHIRO SHIN, MD, PHD, HIROTAKA HASEGAWA, MD, PHD, MASAAKI SHOJIMA, MD, PHD, KENTA OHARA, MD, PHD, YUKI SHINYA, MD, PHD, MARIKO KAWASHIMA, MD, PHD, KENJI KONDO, MD, PHD,NOBUHITO SAITO, MD, PHD: ENDOSCOPIC EXTENDED TRANSSPHENOIDAL SURGERY AIMING FOR RADICAL RESECTION OF SKULL BASE TUMORS INVOLVING CAVERNOUS SINUS: ASSESSMENT OF RESECTABILITY AND RISKS OF COMPLICATIONS: OPERATIVE NEUROSURGERY 25:260¿268, 2023, HTTPS://DOI.ORG/10.1227/ONS.0000000000000749. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE OPERATIVE NEUROSURGERY 25:260¿268, 2023 ARTICLE NAME: ENDOSCOPIC EXTENDED TRANSSPHENOIDAL SURGERY AIMING FOR RADICAL RESECTION OF SKULL BASE TUMORS INVOLVING CAVERNOUS SINUS: ASSESSMENT OF RESECTABILITY AND RISKS OF COMPLICATIONS THAT GTR (GROSS TOTAL RESECTION) WAS ACHIEVED IN 28 PATIENTS (80.0%), SUBTOTAL RESECTION IN 3 (8.6%), AND PARTIAL RESECTION IN 4 (11.4%). ONE PATIENT EXPERIENCED INTERNAL CAROTID ARTERY INJURY DURING SURGERY. AFTER ETS (ENDOSCOPIC TRANSSOPHENOIDAL SURGERY), 15 PATIENTS SHOWED SYMPTOM IMPROVEMENT (51.7% IN ALL 29 PATIENTS WITH PREOPERATIVE CRANIAL NERVE SYMPTOMS, CNS(CRANIAL NERVE SYMPTOMS)). FOUR (11.4%) TRANSIENTLY DEVELOPED ABDUCENS NERVE PALSY, AND ONE REQUIRED REPAIR SURGERY FOR CEREBROSPINAL LEAKAGE. TOTAL, 35 SKULL BASE TUMORS IN CS, AIMING FOR RADICAL RESECTION, WERE INVOLVED IN THIS STUDY. AMONG THE 35 PATIENTS, 17 PATIENTS HAD CHONDROSARCOMAS, 12 HAD CHORDOMAS, 3 HAD MENINGIOMAS, AND 3 HAD TRIGEMINAL SCHWANNOMAS (MEDIAN FOLLOW-UP 36.5 MONTHS RANGING FROM 12 TO 91 MONTHS). A MIDAS REX DRILL SYSTEM WITH A DIAMOND BURR FOR THE LONG AND SLIGHTLY CURVED SHAFT WAS USED FOR REMOVAL OF BONY STRUCTURES. ON FOLLOWUP NO FURHTER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141555 PSS UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS PSS UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other