BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8497605 · Received April 9, 2019

    Report

    Report Number
    9610877-2019-00235
    Event Type
    Malfunction
    Date Received
    April 9, 2019
    Report Date
    March 18, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    PMA / PMN Number
    K131028
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-008-C WHICH INCLUDED INSPECTION OF THE SUCTION ARM ON AFFECTED MODELS PURSUANT TO PREDEFINED INSPECTION CRITERIA ((B)(4)). THE OBJECTIVE OF THE INSPECTION WAS TO LOCATE PART C255-AB171 (SUCTION ARM) AND VERIFY IT IS NOT LOOSE. IF PART C255-AB171 (SUCTION ARM) IS FOUND LOOSE, THE DEVICE WAS CONSIDERED TO FAIL THE INSPECTION CRITERIA. THE CUSTOMER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 14/MAR/2019. INSPECTION OF THE DEVICE WAS PERFORMED ON 18/MAR/2019 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: SUCTION ARM LOOSE, INSERTION TUBE NON-PENTAX MATERIAL, LEAK AT PVE CONNECTOR, FAILED WET LEAK TEST, UMBILICAL CABLE NON-PENTAX MATERIAL, UP/ DOWN BRAKE LEVER CRACKED, DISTAL BODY CHIPPED, UP/ DOWN CONTROL KNOB/ LEVER CRACKED, LIGHTGUIDE PRONG SCRATCHED/ PITTED, FAILED DRY LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET SCRATCHED, LIGHT CARRYING BUNDLE BROKEN, LIGHTGUIDE PRONG COVER GLASS SET DENTED, CHEMICAL RESIDUE BUILDUP ON CONTROL BODY, PRIMARY OPERATION CHANNEL RESISTANCE, CCD CIRCUIT BOARD POOR SOLDER TECHNIQUE, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, IMAGE BLACKOUT. INSPECTION OF THE SUCTION ARM WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA. THE SCOPE'S REPAIRS TO BE PERFORMED WHERE THE LOOSE SUCTION ARM WILL BE CORRECTED, AND THE UNIT RETURNED TO THE USER UPON COMPLETION. PARTS REPLACED: O-RINGS AND SEALS, DISTAL END W/CCD-M PB-FREE/NTSC, INSERTION FLEX TUBE W/SEG PB-FREE, BENDING RUBBER, DISTAL ATTACHING PIN, SEGMENT STEEL BRAID, LIGHT GUIDE CABLE, ELECTRICAL CONNECTOR ASSY, LIGHT GUIDE PRONG IMP-1, LG PRONG INSULATION RING, LG PRONG ATTACHING NUT, LIGHT GUIDE PRONG WASHER IMP-1, LG COVER GLASS SET (LENS TYPE), FRICTION LEVER ASSY, ANGLE LEVER ASSY, INSERTION/S-NIPPLE ATTACHING SCREW, SUCTION CONNECTION TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288465 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB-1170K

    Patients

    Seq Age Sex Outcome Treatment
    1