BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 6784645 · Received August 10, 2017

    Report

    Report Number
    9610877-2017-00408
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    February 23, 2017
    Report Date
    July 13, 2017
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    K961564
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    HOYA CORPORATION PENTAX (B)(4) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX (B)(4). THIS EVENT INVOLVED ONE PATIENT WHO EXPERIENCED TWO SEPARATE ALLERGIC REACTIONS WITH PENTAX MODEL EE-1580K. NUMBER 9610877-2017-00408 IS BEING SUBMITTED FOR THE FIRST OCCURRENCE OF AN ALLERGIC REACTION EXPERIENCED BY THE PATIENT. NUMBER 9610877-2017-00409 IS BEING SUBMITTED FOR THE SECOND OCCURRENCE OF AN ALLERGIC REACTION EXPERIENCED BY THE SAME PATIENT. (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL RECEIVED A REPORT FOR A PATIENT WHO HAD AN ALLERGIC REACTION. THE REPORT STATED "THE PATIENT HAD BEEN SCOPED A NUMBER OF TIMES. ON THE LAST TWO SCOPES, THE PATIENT DEVELOPED A SEVERE RASH AND EDEMA WHICH IS BELIEVED TO HAVE BEEN CONFINED TO THE HEAD AND NECK AREA". THE FACILITY COMMUNICATED ALLERGY TESTING WAS PERFORMED ON THE PATIENT WHICH CONFIRMED THE FOLLOWING: NEGATIVE FOR LIDOCAINE ALLERGY. POSITIVE FOR RUBBER MIX (SEVERE REACTION WITH BLISTERING), THIURAM MIX (RUBBER ACCELERATOR USED IN MANUFACTURING OF RUBBER) AND IODOPROPYNYL BUTYLCARBAMATE (PRESERVATIVE). THE FACILITY ALSO COMMUNICATED THE PATIENT HAS EXPERIENCED REACTIONS WITH SUNSCREENS AND LATEX IS AVOIDED SINCE THE RUBBER MIX USED DURING TESTING INCLUDES LATEX.. THE FACILITY DID NOT RETURN THE GASTROSCOPE TO PENTAX MEDICAL FOR EVALUATION SINCE NO MALFUNCTION OF THE GASTROSCOPE WAS REPORTED TO HAVE OCCURRED. THE FACILITY REQUESTED PENTAX TO PROVIDE INFORMATION ON WHETHER THE MATERIALS THE PATIENT TESTED POSITIVE FOR WERE USED IN THE MANUFACTURING OF THE GASTROSCOPE. A RESPONSE WAS PROVIDED BY THE MANUFACTURER WHICH STATED NONE OF THE MATERIALS THE PATIENT TESTED POSITIVE FOR ARE USED IN THE CONSTRUCTION OF THE PATIENT CONTACT SURFACE OF THE GASTROSCOPE. THIS INFORMATION WAS COMMUNICATED TO THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED BY THE FACILITY FOR BOTH OCCURRENCES WHICH STATED THE PATIENT UNDERWENT A BRONCHOSCOPY PROCEDURE AND OVER THE NEXT FEW HOURS THE PATIENT DEVELOPED A REGIONAL RASH AND SWELLING IN THE NECK AND TORSO. THE EVENTS WERE NOT CONSIDERED LIFE THREATENING AND THE PATIENT DID NOT GO TO EMERGENCY ROOM NOR WAS ADMITTED TO THE HOSPITAL. NO TREATMENT WAS PROVIDED FOR THE FIRST OCCURRENCE. A MEDROL DOSE PACK WAS GIVEN FOR THE SECOND OCCURRENCE. THE FACILITY ALSO STATED THE PATIENT IS CURRENTLY AT BASELINE HEALTH. A SERIAL NUMBER FOR THE GASTROSCOPE WAS NOT PROVIDED BY THE FACILITY.

    Additional Manufacturer Narrative · 1

    HOYA CORPORATION PENTAX (B)(4), SPECIFICATION DEVELOPER, REGISTRATION NO. 9610877. PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. 2518897. PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX (B)(4) (EXEMPTION NUMBER E2015036). THIS EVENT INVOLVED ONE PATIENT WHO EXPERIENCED TWO SEPARATE ALLERGIC REACTIONS WITH PENTAX MODEL EE-1580K. 9610877-2017-00408 IS BEING SUBMITTED FOR THE FIRST OCCURRENCE OF AN ALLERGIC REACTION EXPERIENCED BY THE PATIENT. 9610877-2017-00409 IS BEING SUBMITTED FOR THE SECOND OCCURRENCE OF AN ALLERGIC REACTION EXPERIENCED BY THE SAME PATIENT.

    Description of Event or Problem · 1

    A DEFINITIVE SERIAL NUMBER FOR THE ESOPHAGOSCOPE COULD NOT BE DETERMINED, AS A SEARCH OF THE PENTAX INTERNAL ENTERPRISE RESOURCE PLANNING (ERP) SYSTEM SHOWS THE FACILITY HAS MULTIPLE UNITS OF THIS MODEL IN THEIR POSSESSION. SINCE THE USER DID NOT RETURN THE UNIT FOR EVALUATION, AND IT FUNCTIONED AS INTENDED, AND THE SERIAL NUMBER FOR THE ESOPHAGOSCOPE COULD NOT BE DETERMINED, A DEVICE HISTORY REVIEW AND SERVICE HISTORY WERE UNABLE TO BE PERFORMED. PENTAX MEDICAL HAS NOT RECEIVED FURTHER INFORMATION FOR THIS EVENT, AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564981 PENTAX VIDEO ESOPHAGOSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EE-1580K

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR