BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX

    MDR report key: 13674079 · Received March 4, 2022

    Report

    Report Number
    2027111-2022-00441
    Event Type
    Malfunction
    Date Received
    March 4, 2022
    Date of Event
    February 7, 2022
    Report Date
    May 23, 2022
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    HET
    UDI-DI
    00607915110123
    PMA / PMN Number
    K062169
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. TESTING WAS PERFORMED ON THE EVENT UNIT, WHICH CONFIRMED THAT THE RETURNED UNIT WAS UNABLE TO CUT CONSISTENTLY ACROSS THE ENTIRE LENGTH OF THE BLADE. ENGINEERING OBSERVED A SMALL GAP BETWEEN THE TIPS OF THE BLADES. BASED ON THE CONDITION OF THE EVENT UNIT AND DESCRIPTION OF THE EVENT, THE SCISSORS WERE UNABLE TO CUT DUE TO THE GAP THAT WERE OBSERVED BETWEEN THE TIPS OF THE BLADES ON THE RETURNED UNIT.  HOWEVER, THE EXACT ROOT CAUSE OF THE GAP COULD NOT BE DETERMINED BASED ON THE EVALUATION OF THE RETURNED UNIT. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION, AND EASE OF USE OF ITS PRODUCTS.  AS PART OF THIS PROCESS, APPLIED MEDICAL IS CURRENTLY RESEARCHING POSSIBLE ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: INGUINAL HERNIA . DETAILED DESCRIPTION OF EVENT: SCISSORS NOT SHARP AT THE DISTAL END WHICH MAKES DISSECTION DURING PROCEDURE MORE DANGEROUS. THIS IS A RETURNING PROBLEM FOR DR [NAME] AND WAS REPORTED IN AN EARLIER CER: 2021-000813 (MFR 2027111-2021-00437), 2021-000814 (MFR 2027111-2021-00438), 2021-000815 (MFR 2027111-2021-00439). UNTIL NOW NO PATIENT WAS HARMED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 11-FEB-2022: UNTIL NOW NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23-FEB-2022: NO PATIENT WAS INJURED. PATIENT STATUS: NO PATIENT INJURY.

    Description of Event or Problem · 0

    NAME OF PROCEDURE BEING PERFORMED: INGUINAL HERNIA. DETAILED DESCRIPTION OF EVENT: SCISSORS NOT SHARP AT THE DISTAL END WHICH MAKES DISSECTION DURING PROCEDURE MORE DANGEROUS. THIS IS A RETURNING PROBLEM FOR DR [NAME] AND WAS REPORTED IN AN EARLIER CER: (B)(4) (MFR 2027111-2021-00437), (B)(4) (MFR 2027111-2021-00438), (B)(4) (MFR 2027111-2021-00439). UNTIL NOW NO PATIENT WAS HARMED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 11-FEB-2022: UNTIL NOW NO PATIENT INJURY OCCURRED. ADDITIONAL INFORMATION RECEIVED FROM APPLIED MEDICAL REPRESENTATIVE VIA EMAIL ON 23-FEB-2022: NO PATIENT WAS INJURED. PATIENT STATUS: NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030447 CB030, 5MMX35CM EPIX LAPA SCISSOR, 10/BX LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) HET APPLIED MEDICAL RESOURCES CB030 1435498 00607915110123

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown