BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX

    MDR report key: 9730048 · Received February 19, 2020

    Report

    Report Number
    2027111-2020-00370
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 23, 2020
    Report Date
    March 23, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DSS
    UDI-DI
    00607915115074
    PMA / PMN Number
    K883909
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. AS THE EVENT UNIT WAS NOT RETURNED, TESTING WAS UNABLE BE PERFORMED AND THE COMPLAINANT¿S EXPERIENCE COULD NOT BE REPLICATED OR CONFIRMED. BASED ON THE EVENT DESCRIPTION AND PREVIOUS EVENTS THAT WERE REPORTED TO APPLIED, IT IS LIKELY THAT THE REPORTED EVENT WAS CAUSED BY INTERFERENCE BETWEEN THE MALE AND FEMALE JAW COMPONENTS. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL HAS RECENTLY IMPLEMENTED PROCESS ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 0

    THE CLIP REMAINED BLOCKED IN THE OPEN POSITION WHEN THE SURGEON WANTED TO CLAMP THE MAMMARY ARTERY. CLINICAL CONSEQUENCE: NONE. THIS INCIDENT TOOK PLACE AT THE CTCV BLOCK ON (B)(6) 2020 AND ON (B)(6) 2020. ORIGINAL : LE CLIP EST RESTÉ BLOQUÉ EN POSITION OUVERTE LORSQUE LE CHIRURGIEN A VOULU CLAMPER L'ARTÈRE MAMMAIRE. CONSÉQUENCE CLINIQUE : AUCUNE. CET INCIDENT A EU LIEU AU BLOC CTCV LE (B)(6) 2020 ET LE (B)(6) 2020. CLINICAL CONSEQUENCE: NONE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: NI. THE CLIP REMAINED BLOCKED IN THE OPEN POSITION WHEN THE SURGEON WANTED TO CLAMP THE MAMMARY ARTERY. CLINICAL CONSEQUENCE: NONE. THIS INCIDENT TOOK PLACE AT THE CTCV BLOCK ON (B)(6) 2020 AND ON (B)(6) 2020. ORIGINAL : LE CLIP EST RESTÉ BLOQUÉ EN POSITION OUVERTE LORSQUE LE CHIRURGIEN A VOULU CLAMPER L'ARTÈRE MAMMAIRE. CONSÉQUENCE CLINIQUE : AUCUNE. CET INCIDENT A EU LIEU AU BLOC CTCV LE (B)(6) 2020 ET LE (B)(6) 2020. INTERVENTION: NI. PATIENT STATUS: CLINICAL CONSEQUENCE: NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191540 A1602, 6MM L/L STEALTH CLIP 1/4 F 10/BX CLIP, VASCULAR DSS APPLIED MEDICAL RESOURCES A1602 1360356 00607915115074

    Patients

    Seq Age Sex Outcome Treatment
    1