BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-PET ADJUSTABLE HANDLE SET

    MDR report key: 23975122 · Received January 6, 2026

    Report

    Report Number
    1820334-2026-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    December 19, 2025
    Report Date
    February 2, 2026
    Manufacturer
    COOK INC
    Product Code
    MQJ
    UDI-DI
    00827002186743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5, D9. H3 ¿ THE DEVICE IS NOT BEING RETURNED FOR EVALUATION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    E1 - PHONE NUMBER: (B)(6). E1 - ADDRESS: (B)(6). G4 - PMA/510(K) #: EXEMPT. H3 - DEVICE RETURN STATUS UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 16JAN2026. THE HANDLE WAS NOT PREVIOUSLY USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEAD OF THE HANDLE FROM A FLEXI-PET ADJUSTABLE HANDLE SET WAS NOTED TO BE SCRATCHED AND DIRTY UPON OPENING THE PACKAGING PRIOR TO USE FOR AN UNKNOWN PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38855 FLEXI-PET ADJUSTABLE HANDLE SET MQJ MICROMANIPULATORS AND MICROINJECTORS, ASSISTED REPRODUCTION MQJ COOK INC G18674 15950478 00827002186743

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown