BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 7101930 · Received December 8, 2017

    Report

    Report Number
    9610877-2017-00672
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    November 7, 2017
    Report Date
    November 9, 2017
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    K131855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOYA CORPORATION PENTAX TOKYO OFFICE, SPECIFICATION DEVELOPER. (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT ON (B)(4) 2017 STATING A PATIENT EXPERIENCED SUDDEN COLITIS FOLLOWING A PROCEDURE WITH PENTAX MODEL EC38-I10L/SERIAL (B)(4). PENTAX MEDICAL SUBMITTED A GOOD FAITH EFFORT TO THE CUSTOMER IN ORDER TO GATHER DETAILS ON THE PATIENT, EVENT, AND REPROCESSING TECHNIQUES FOLLOWED AT THE FACILITY. THE COLONOSCOPE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION. THE PENTAX MEDICAL INSPECTIONAL FINDINGS INCLUDED THE FOLLOWING: -OPERATION CHANNEL - PRIMARY SLICE BY ACCESSORY. -PASSED DRY/WET LEAK TESTS. -WATER NOZZLE GLUE MISSING. -SUCTION TUBE RESISTANCE. THE REGIONAL SERVICE MANAGER VISITED THE FACILITY ON 29/NOV/2017 TO OBSERVE THE PROCESS FOR THE UPPER/LOWER GI ENDOSCOPE HANDLING AND REPROCESSING. THE REGIONAL SERVICE MANAGER OBSERVATIONS ARE AS FOLLOWS: THE ENDOSCOPES ARE TRANSPORTED INTO THE "UNCLEAN" SIDE OF THE CLEANING ROOM IN COVERED TRAYS. THE TECHNICIAN'S WEAR GLOVES IN ALL AREAS OF THE ROOM. THE ENDOSCOPES ARE THEN REPROCESSED ACCORDING TO THE PENTAX IFU UP TO THE POINT OF ENZYMATIC FLUSHING, AT WHICH POINT THE MEDIVATORS SCOPE BUDDY IS UTILIZED. THE MEDIVATORS SCOPE BUDDY IS SET FOR A 3-MINUTE CYCLE. AFTER THE MANUAL WASHING, BRUSHING, FLUSHING PROCESS IS COMPLETED UTILIZING J & J ASP ENZOL AND PENTAX MODEL CS-6021T AND CS-C9S BRUSHES AND THE MEDIVATORS SCOPE BUDDY, THE ENDOSCOPE IS PLACED IN THE MEDIVATORS ADVANTAGE PLUS AER. 2-8-537-HAN MEDIVATORS BLOCK FOR THE AER IS USED. THE AER HAS A CYCLE FOR HLD USING RAPACIDE PA. AT THE END OF THE FINAL RINSE CYCLE, THE AER FLUSHES 70% ISOPROPYL ALCOHOL THROUGH ALL LUMENS OF THE ENDOSCOPE. THE ALCOHOL IS THEN PURGED OUT OF THE ENDOSCOPE CHANNELS WITH AIR AS PROVIDED BY THE AER. THE PENTAX MODEL CS-C9S BRUSHES ARE ALSO MANUALLY CLEANED, RINSED, AND PLACED INTO THE MEDIVATORS ADVANTAGE PLUS AER FOR HLD WITH RAPICIDE PA. THE ENDOSCOPES ARE THEN REMOVED FROM THE AER AND PLACED ON A COUNTERTOP DESIGNED FOR SECONDARY DRYING ON THE CLEAN SIDE OF THE ROOM. THE TECHNICIAN MANUALLY BLOWS THE CHANNELS DRY WITH AN AIR DELIVERY DEVICE/TUBE (FORCED AIR) SET AT 22 PSI. THE REGIONAL SERVICE MANAGER USED THE FORCED AIR ON MULTIPLE ENDOSCOPES THAT WERE ALREADY DRIED AND WAS ABLE TO PURGE ADDITIONAL ALCOHOL FROM THE CHANNELS. THE LEFTOVER ALCOHOL WAS MOSTLY IN THE AIR/WATER DELIVERY TUBES OF THE COLONOSCOPES. THERE WAS A BIT LESS IN THE FORWARD WATER JET TUBE AND LESS IN THE BIOPSY/SUCTION TUBES. THE REGIONAL SERVICE MANAGER OBSERVED THE TECHNICIAN'S TECHNIQUE OF AIR DRYING THE ENDOSCOPES AND NOTICED THAT THE TECHNICIANS USE THEIR FINGERS TO COVER THE AIR/WATER OR SUCTION CYLINDER ON THE HANDLE OF THE ENDOSCOPE AS THEY ARE DRYING THE RESPECTIVE CHANNEL. REPAIRS WERE PERFORMED ON THE COLONOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: -SEGMENT STAYCOIL ASSY PB-FREE, -STAYCOIL COLLAR, -INSERTION FLEX TUBE, -DISTAL END ASSY WITH TUBES, -DISTAL ATTACHING PLATE, -DISTAL AND SEGMENT ATTACHING SCREW, -BENDING RUBBER, -ADJUSTING COLLAR, -RL/UD PULLEY ASSY, -SUCTION CHANNEL LG. THE COLONOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 05/DEC/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880560 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other