BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 9468453 · Received December 13, 2019

    Report

    Report Number
    2027111-2019-00663
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    November 19, 2019
    Report Date
    March 6, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    UDI-DI
    00607915110123
    PMA / PMN Number
    K062169
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. HOWEVER, REPRESENTATIVE STERILE UNITS WERE RETURNED. TESTING WAS PERFORMED ON THE REPRESENTATIVE UNITS. ENGINEERING WAS UNABLE CONFIRM THAT THE SCISSOR BLADES WERE DULL AND THE COMPLAINANT¿S EXPERIENCE COULD NOT BE REPLICATED. THE REPRESENTATIVE UNITS MET CURRENT SPECIFICATIONS AND THERE WERE NO VISIBLE NON-CONFORMANCES. IN THE ABSENCE OF THE EVENT UNIT, IT IS DIFFICULT TO DETERMINE THE EXACT ROOT CAUSE OF THE EVENT. THE PROBABILITY AND CRITICALITY OF HARM RESULTING FROM THIS FAILURE HAVE BEEN EVALUATED AND WERE FOUND TO BE AT AN ACCEPTABLE LEVEL.

    Description of Event or Problem · 0

    CER 1 OF 2 - 2019-002799; CER 2 OF 2 - 2019-002800. PROCEDURE PERFORMED: LAP CHOLE. RELATING TO CER 0001014453, A SECOND PAIR OF SCISSORS WERE OPENED AND FOUND TO ALSO BE BLUNT. THESE SCISSORS CAME FROM THE SAME LOT NUMBER AS THOSE IN CER 0001014453. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON DECEMBER 2, 2019 FROM CUSTOMER RELATIONS THE TWO EVENT SAMPLES HAVE NOT BEEN RETURNED. INTERVENTION: PRODUCT WAS REPLACED WITH ANOTHER. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION BUT LOT # IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: LAP CHOLE. CER 1 OF 2 - (B)(4). CER 2 OF 2 - (B)(4). RELATING TO CER (B)(4), A SECOND PAIR OF SCISSORS WERE OPENED AND FOUND TO ALSO BE BLUNT. THESE SCISSORS CAME FROM THE SAME LOT NUMBER AS THOSE IN CER (B)(4). ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON DECEMBER 2, 2019 FROM CUSTOMER RELATIONS (B)(6). THE TWO EVENT SAMPLES HAVE NOT BEEN RETURNED. PATIENT STATUS: PATIENT IS FINE, AND COMPLETELY UNAFFECTED INTERVENTION: PRODUCT WAS REPLACED WITH ANOTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263866 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1361436 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1