BEUDAMED
    FDA Adverse Event Other Summary report: N

    FORCEPS, 2MM GRASPING

    MDR report key: 5313578 · Received September 22, 2004

    Report

    Report Number
    2183911-2004-00003
    Event Type
    Other
    Date Received
    September 22, 2004
    Date of Event
    September 20, 2004
    Manufacturer
    CLARUS MEDICAL, LLC.
    Product Code
    HTD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONSIDERING THE OBSERVATIONS OF THE BREAK POINT (SEE ATTACHED TEST REPORT/EVALUATION), THE CONCLUSION IS THAT EXCESSIVE FORCE WAS APPLIED SOMEHOW TO THE JAW OF THE FORCEPS EITHER DURING USE OR DURING CLEANING BETWEEN USES AND THE DAMAGE WAS NOT NOTED BEFORE THIS FINAL USE OR DURING USE.

    Description of Event or Problem · 1

    ON (B)(6) 2004 CLARUS MEDICAL RECEIVED A PHONE CALL FROM A SALES REP REPORTING A PRODUCT PROBLEM. HE REPORTED THAT ON (B)(6) 2004, THE JAW OF THE FORCEPS 3220-002 BROKE OFF INSIDE AN INTRAVERTEBRAL DISC, DURING A PERCUTANEOUS LUMBAR DISCECTOMY PROCEDURE. THE ACTUAL FORCEPS RETURNED TO CLARUS WAS A MODEL 3240-002. I ASSUME THE INITIAL REPORT WAS IN ERROR AS TO THE MODEL NUMBER. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE MISSING PORTION OF THE JAW FRO THE DISC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCEPS, 2MM GRASPING FORCEPS HTD CLARUS MEDICAL, LLC. 3240-002 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other