BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MF IRR/TI 8 3/4 .5MM TIP

    MDR report key: 14858709 · Received June 29, 2022

    Report

    Report Number
    3014334038-2022-00138
    Event Type
    Injury
    Date Received
    June 29, 2022
    Date of Event
    June 13, 2022
    Report Date
    January 19, 2024
    Manufacturer
    RAYNHAM
    Product Code
    GEI
    UDI-DI
    10381780516248
    PMA / PMN Number
    K963499
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED: PATIENT AGE AND GENDER - FEMALE / 68 YEARS OLD. NAME OF PROCEDURE PERFORMED - MICRODISCECTOMY IN L 3/4, LT. DID THE REPORTED EVENT CAUSE ANY DELAYS IN THE PROCEDURE OR SURGERY OVER 30 MINUTES? IT TOOK ABOUT ONE MORE HOUR TO CHECK WHETHER CSF LEAKAGES OR NOT. WHAT WAS THE EXTENT OF THE BURN ¿ WAS IT SUPERFICIAL? HOW LARGE WAS IT? DAMAGE TO THE DURA HAS BEEN IDENTIFIED. ABOUT 5MM X 5MM. LOCATION OF THE BURN? L 3/4 THECAL SAC. WAS TREATMENT OF THE BURN NECESSARY? YES, WE USED THE DURA MATER SUPPLEMENT. WHAT IS THE CURRENT STATUS OF THE BURN? FORTUNATELY, CSF LEAK DID NOT OCCUR, BUT IF IT DID, MORE AGGRESSIVE SURGERY WOULD HAVE BEEN PERFORMED.

    Additional Manufacturer Narrative · 0

    THE REUSABLE FORCEPS (ID 802902) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THERE IS NO INDICATION THAT THE PRODUCTION PROCESS MAY HAVE CONTRIBUTED TO THIS COMPLAINT. ALL TEST RESULTS PASSED PROCEDURAL SPECIFICATIONS. FAILURE ANALYSIS - THE FORCEPS UNIT WAS INSPECTED BY THE FAILURE ANALYST. THE FAILURE ANALYST NOTED THAT THE FORCEPS WERE MISSING THEIR SILVER TIPS, INDICATING SOME SORT OF MANUFACTURING DEFECT. FUNCTIONAL TESTING NOT RECOMMENDED OR NEEDED DUE TO DEFECT. THE COMPLAINT COULD BE VERIFIED THROUGH FAILURE ANALYSIS. THE ROOT CAUSE IS UNDETERMINED AND WAS UNABLE TO BE CONFIRMED IN THE COMPLAINT EVALUATION. A DEVICE HISTORY RECORD (DHR) REVIEW AND TRENDING WERE PERFORMED AS PART OF THE EVALUATION. PRODUCT WAS RECEIVED FOR ANALYSIS AND THE INVESTIGATION COULD NOT CONFIRM THE COMPLAINT. THE RISK REMAINS ACCEPTABLE PER THE RISK ANALYSIS. POSSIBLE ROOT CAUSE IS ¿LOSS / UNCONTROLLED THERMAL CONDUCTIVITY¿ OR ¿EXCESSIVE HEAT BUILDUP¿.

    Description of Event or Problem · 0

    A FACILITY REPORTED A BURNOUT OF THE SURGICAL SITE WHILE USING A REUSABLE FORCEPS (B)(4). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AFTER SEVERAL ATTEMPTS.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846189 MF IRR/TI 8 3/4 .5MM TIP REUSABLE FORCEPS GEI RAYNHAM 802902 985460 10381780516248

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female