BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVH

    MDR report key: 20267395 · Received September 20, 2024

    Report

    Report Number
    2242352-2024-0001055
    Event Type
    Malfunction
    Date Received
    September 20, 2024
    Date of Event
    August 26, 2024
    Report Date
    November 27, 2024
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GCJ
    UDI-DI
    00607567700802
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TW # (B)(4).

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). CORRECTED SECTIONS: H6--TYPE OF INVESTIGATION CORRECTED FROM "4114" TO "10" H6--INVESTIGATION FINDINGS CODE "3233" REMOVED THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 11/19/2024. AN INVESTIGATION WAS CONDUCTED ON 11/26/2024. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND NO EVIDENCE OF BLOOD WAS OBSERVED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT ENDOSCOPE. AN IMAGE QUALITY INSPECTION WAS PERFORMED WITH AN ENDOSCOPIC VIDEO IMAGING SYSTEM. A CLEAR IMAGE WAS ABLE TO BE OBTAINED. BASED UPON THE RECEIVED CONDITION OF THE DEVICE, IT IS NOT POSSIBLE TO CONFIRM THE REPORTED COMPLAINT AS THERE WAS NO DEVICE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    TRACKWISE#: (B)(4). UPDATED SECTIONS: B4, G3, G6, H2, H6, H11. CORRECTED SECTIONS: D4--UNIQUE IDENTIFIER (UDI) # CORRECTED (B)(4). A LOT HISTORY SEARCH IS NOT APPLICABLE BECAUSE THIS IS A REUSABLE, OEM DEVICE. DUE TO THE AGE OF THE DEVICE, A C OF C IS NOT READILY AVAILABLE ON-SITE.

    Additional Manufacturer Narrative · 0

    TW ID#: (B)(4) THE DEVICE HAS NOT YET BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR EVALUATION. WE ARE FOLLOWING UP WITH THE CUSTOMER FOR THE RETURN OF THE DEVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    THE HOSPITAL REPORTED THAT 7MM EXTENDED LENGTH ENDOSCOPE OPTICS DEFECTIVE DUE TO WEAR AND TEAR AND DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496068 EVH LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CARDIOVASCULAR LLC 7MM EXTENDED LENGTH ENDOSCOPE N/A 00607567700802

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.