BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 6586147 · Received May 23, 2017

    Report

    Report Number
    9610877-2017-00032
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    January 27, 2017
    Report Date
    April 24, 2017
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EQL
    PMA / PMN Number
    REFER TO H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTACT OFFICE: (B)(4)., MDRS 9610877-2017-00027, 9610877-2017-00030, 9610877-2017-00031, 9610877-2017-00032, AND 9610877-2017-00033 ARE BEING SUBMITTED FOR THE 5 PATIENTS. PMA 510(K): PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE PRODUCT CODE IS CLASS 1, EXEMPT FROM PMA/510(K). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT STATING A PATIENT EXPERIENCED AN ALLERGIC REACTION DURING A PROCEDURE WITH A PENTAX ENDOSCOPE. NO FURTHER INFORMATION ON THE PATIENT OR THE ENDOSCOPE WAS PROVIDED AT THE TIME OF THE REPORT. A MEETING WAS HELD WITH THE FACILITY ON 04/25/2017 IN WHICH THE FACILITY STATED SEVERAL INCIDENCES HAVE OCCURRED DURING PROCEDURE WITH PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE MODEL VNL-1190STK/SERIAL NUMBER (B)(4). THE INSTANCES HAVE BEEN OCCURRING MORE FREQUENTLY WHICH PROMPTED THE FACILITY TO NOTIFY PENTAX. THE EVENTS WERE DESCRIBED AS FOLLOWS: IT WAS OBSERVED, DOWN THE NASAL CAVITY AND BACK INTO THE NASAL PHARYNX, THAT PATIENTS WERE EXPERIENCING REACTIONS (THERMAL/CHEMICAL INJURIES/BURNS TO THE TISSUES). PATIENTS HAVE HAD TO GO TO THE ER TO RECEIVE TREATMENT. IN ADDITION, DURING THE MEETING, THE FACILITY STATED THE INSTRUCTIONS FOR USE FOR THIS MODEL ENDOSCOPE IS FOLLOWED METICULOUSLY AND THERE HAVE BEEN NO ISSUES WITH THIS ENDOSCOPE SINCE ACQUISITION IN 10/2013. THE ENDOSCOPE WAS REMOVED FROM USE AFTER THE EVENT OCCURRED ON (B)(6) 2017 AND SENT INTO PENTAX FOR EVALUATION. THE PENTAX MEDICAL INSPECTION FINDINGS INCLUDED THE FOLLOWING: -FLUID INVASION IN SEGMENT SECTION. -IMAGE ALIGNMENT OUT. -VERTICAL LINES IN IMAGE. -FAILED WET AND DRY LEAK TEST. -SEGMENT STEEL BRAID TWISTED. -UP/DOWN CONTROL KNOB/LEVER TENSION. -INSERTION TUBE SEVERE COIL SHIFTING AT STAGE 1. -BENDING RUBBER PINHOLE. -SEGMENT CORRODED. -VIDEO IMAGE HAS A WHITE OR RED DOT. -UP ANGULATION DECREASED. -BENDING RUBBER LOOSE. -INSERTION TUBE BUCKLES AT STAGE 1. -INSERTION TUBE SEVERE DISCOLORATION AT STAGE 1. IN ADDITION, A DIELECTRIC STRENGTH TEST (THE ABILITY FOR THE DEVICE TO HANDLE OVER VOLTAGE) AND A PATIENT LEAKAGE CURRENT TEST WERE PERFORMED (VOLTAGE GOING FROM ENDOSCOPE TO PATIENT). THE ENDOSCOPE DID FAIL DS TEST. THE PLC TEST WAS HIGHER THAN NORMAL BUT DID NOT FAIL THE TEST. REPAIRS WERE PERFORMED ON THE ENDOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: -O-RINGS AND SEALS. -DISTAL END W/CCD-M PB-FREE/NTSC USA. -DISTAL ATTACHING PIN. -INSERTION FLEX TUBE W/SEG PB-FREE. -BENDING RUBBER. THE DEVICE WAS RETURNED TO THE CUSTOMER ON 05/08/2017. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FACILITY ON 05/16/2017 INDICATING 5 PATIENTS EXPERIENCED ADVERSE REACTIONS DURING PROCEDURE WITH THE DEVICE IDENTIFIED IN THIS MDR. A SEPARATE MDR IS BEING SUBMITTED FOR EACH PATIENT. THE EVENT DETAILS RELATED TO THE PATIENT IDENTIFIED IN THIS MDR ARE AS FOLLOWS: TOPICAL ANESTHETIC WAS APPLIED TO RNARES. DISTAL CHIP SCOPE WAS PASSED TRANSNASALLY ON R AT APPROX 930AM. VIDEOSTROBE EXAM COMPLETED. PATIENT WAKED TO CHECK OUT INDEPENDENTLY AFTER EXAM, BUT VERBALIZED, "FEELING FAINT". CHECK OUT STAFF HAD PATIENT SIT; SLP, MA AND MD WERE OBTAINED. PATIENT WAS GUIDED TO EXAM ROOM AND PLACED IN SUPINE POSITION. MD HAD RESCUE CALLED (911) AND PATIENT WAS TAKEN TO EMERGENCY ROOM. FOLLOW UP FOR THE PATIENT WAS DESCRIBED AS ROUTINE AND ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366909 PENTAX VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE EQL HOYA CORPORATION PENTAX TOKYO OFFICE VNL-1190STK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R