BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 6547381 · Received May 5, 2017

    Report

    Report Number
    9610877-2017-00025
    Event Type
    Malfunction
    Date Received
    May 5, 2017
    Report Date
    April 6, 2017
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PENTAX VIDEO COLONOSCOPE MODEL EC-3890FI2 IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN (B)(6) REGARDING CONTAMINATION OF PENTAX MODEL EC38-I10F2/A110900. DETAILS REGARDING THE CONTAMINATION WERE NOT PROVIDED AT THE TIME OF THE REPORT. THE REPORT ALSO STATED THE ENDOSCOPE WILL BE REPROCESSED A SECOND TIME AT THE CUSTOMER'S SITE. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY STATED THE FIRST SAMPLING PERFORMED ON (B)(6) 2017 DETECTED PRESENCE OF (B)(6) AT A RATE > 100 CFU. THE FACILITY REPROCESSED THE DEVICE A SECOND TIME AND A SECOND SAMPLING WAS PERFORMED ON (B)(6) 2017. THE RESULTS OF THE SECOND SAMPLING CONFIRMED THE DEVICE CONFORMED PER (B)(6) REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329679 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10F2

    Patients

    Seq Age Sex Outcome Treatment
    1