BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOM 7MM EXTENDED LENGTH ENDOSCOPE

    MDR report key: 6302148 · Received February 3, 2017

    Report

    Report Number
    2242352-2017-00098
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 9, 2017
    Report Date
    February 3, 2017
    Manufacturer
    MAQUET CV
    Product Code
    GCJ
    PMA / PMN Number
    K014250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REUSABLE OEM DEVICE; THEREFORE, A LOT HISTORY REVIEW IS NOT APPLICABLE. BASED ON THE SERIAL NUMBER PROVIDED, WE WERE UNABLE TO FIND WHEN THE DEVICE WAS SOLD TO THE ACCOUNT. THE CERTIFICATE OF CONFORMANCE (C OF C) WAS NOT AVAILABLE FOR REVIEW BECAUSE, THE REPORTED SERIAL NUMBER DOES NOT APPEAR TO BE INCLUDED IN ANY OF THE BATCHES RECEIVED IN MAQUET (B)(4).

    Description of Event or Problem · 1

    CRACKED LENSE ON PROBE. CRACKED LENSE NO PATIENT INVOLVEMENT. SUMMARY: THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE LENSES WERE CRACKED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Description of Event or Problem · 1

    CRACKED LENSE ON PROBE. CRACKED LENSE NO PATIENT INVOLVEMENT. SUMMARY: THE HOSPITAL REPORTED THAT DURING PREPARATION FOR AN ENDOSCOPIC VEIN HARVESTING PROCEDURE, BOM 7MM EXTENDED LENGTH ENDOSCOPE LENSES WERE CRACKED. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82410 BOM 7MM EXTENDED LENGTH ENDOSCOPE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ MAQUET CV 352319

    Patients

    Seq Age Sex Outcome Treatment
    1