BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 6415301 · Received March 17, 2017

    Report

    Report Number
    9610877-2017-00010
    Event Type
    Injury
    Date Received
    March 17, 2017
    Report Date
    February 16, 2017
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    K131855
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    HOYA CORPORATION PENTAX TOKYO OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX TOKYO OFFICE (EXEMPTION NUMBER E2015036). MDR 9610877-2017-00010 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00011 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00012 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00013 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00014 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). METHOD CODE(S): MANUFACTURING REVIEW FDA 3317. RESULT CODE(S): OPERATIONAL PROBLEM FDA 114. STIFFNESS PROBLEM FDA 3242. CONCLUSION CODE(S): USE ERROR CAUSED OR CONTRIBUTED TO EVENT FDA 61.

    Additional Manufacturer Narrative · 0

    (B)(4). MDR 9610877-2017-00010 IS BEING SUBMITTED FOR (B)(4). MDR 9610877-2017-00011 IS BEING SUBMITTED FOR (B)(4). MDR 9610877-2017-00012 IS BEING SUBMITTED FOR (B)(4). MDR 9610877-2017-00013 IS BEING SUBMITTED FOR (B)(4). MDR 9610877-2017-00014 IS BEING SUBMITTED FOR (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED ON 13FEB2018 CONFIRMING THE SCOPE HAD AN IMAGE FAILURE FOUND DURING IN-PROCESS INSPECTION AND REQUIRED REWORK IN THE FORM OF A DRIVER BOARD EXCHANGE. THERE WERE NO NONCONFORMANCE FOUND DURING FINAL INSPECTION, NO CONCESSIONS, AND WAS RELEASED ACCORDINGLY. ALSO, DATES OF MANUFACTURING COMPLETION, APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. THE REPAIR HISTORY SHOWS THE ENDOSCOPE WAS RECEIVED ON 08DEC2016 FOR A MAJOR REPAIR PRIOR TO THE REPORTED COMPLAINT. FURTHER INVESTIGATION WAS PERFORMED BY THE MANUFACTURER (SEE INVESTIGATION REPORT NO. (B)(4) FOR DETAILS). THE REPORT DOCUMENTS INSTRUCTION FOR USE (IFU) Z974, 2-2(PG 14) INSPECTION OF ENDOSCOPE. SECTION 3.0) INSPECTION OF ANGULATION CONTROLS AND LOCKS. SLOWLY MANIPULATE THE UP/DOWN AND RIGHT/LEFT CONTROL KNOBS TO SEE THAT THEY FUNCTION SMOOTHLY. BE CERTAIN THAT A FULL AND APPROPRIATE RANGE OF ANGULATION IS POSSIBLE. CAUTION: ANY LACK OF SMOOTH OPERATION OF THE ANGULATION CONTROLS MAY BE EARLY INDICATION OF INTERNAL DAMAGE TO AND /OR PARTS FAILURE WITHIN THE ENDOSCOPE'S ANGULATION SYSTEM. TO AVOID THE POSSIBILITY OF FURTHER ENDOSCOPE DAMAGE OR THE POTENTIAL FOR MALFUNCTION OF THE ANGULATION SYSTEM, DO NOT USE THE ENDOSCOPE IF THE ANGULATION MECHANISM DOES NOT OPERATE PROPERLY. PRIOR TO USE ENSURE THAT THE ANGULATION CONTROLS CAN ROTATE SMOOTHLY, THAT THERE IS NO GRINDING OR EXCESS FRICTION WITHIN THE ANGULATION SYSTEM AND THAT THE DISTAL BENDING SECTION BENDS FREELY AND SMOOTHLY. NEVER APPLY EXCESSIVE FORCE TO THE ANGULATION CONTROLS! PER THE MANUFACTURER'S REPORT, THIS COMPLAINT COULD HAVE BEEN AVOIDED, BY FOLLOWING THE IFU. THE TIGHT KNOBS SHOULD HAVE BEEN IDENTIFIED DURING PRE-PROCEDURE INSPECTION AND THE ENDOSCOPE SENT FOR SERVICE. ADDITIONALLY, ONCE RESISTANCE WAS ENCOUNTERED BY THE PHYSICIAN, THE USE OF THE SCOPE SHOULD HAVE BEEN DISCONTINUED, RATHER THAN APPLY EXCESS FORCE RESULTING IN THE USER BLISTERING AND RISKING POTENTIAL FURTHER DAMAGE TO THE ENDOSCOPE AND/OR THE POSSIBILITY OF A "FROZEN" DISTAL BENDING SECTION. A "FROZEN" BENDING SECTION CAN MAKE INSTRUMENT EXTRACTION FROM A PATIENT MORE DIFFICULT. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR EVENTS WHICH OCCURRED IN (B)(6) STATING FOR 5 DIFFERENT COLONOSCOPES (SAME MODEL AND 5 DIFFERENT SERIAL NUMBERS), FOR WHICH A PHYSICIAN FEELS THE KNOBS ARE TOO TIGHT. THE COLONOSCOPES CAUSED BLISTERS TO THE PHYSICIAN BECAUSE THE PHYSICIAN NEEDS TO FORCE THE KNOBS TO MAKE THE SCOPE DISTAL TIP MOVE. NO PATIENT CONSEQUENCES WERE REPORTED. PENTAX (B)(4) REQUESTED THE COLONOSCOPES BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PHYSICIAN SUFFERED FROM HYPEROSTOSE, HOWEVER ACCORDING THE PHYSICIAN SHE DID NOT SEEK MEDICAL ATTENTION AS A RESULT OF THE EVENTS AND CONTINUES TO WORK WITH OTHER COLONOSCOPES OF THE SAME MODEL.

    Additional Manufacturer Narrative · 1

    HOYA CORPORATION PENTAX (B)(4) OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. 9610877 PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX (B)(4) OFFICE (EXEMPTION NUMBER E2015036). MDR 9610877-2017-00010 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00011 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00012 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00013 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4). MDR 9610877-2017-00014 IS BEING SUBMITTED FOR MODEL EC38-I10L/SERIAL (B)(4).

    Description of Event or Problem · 1

    PENTAX (B)(4) SUBMITTED A FINAL REPORT TO HEALTH (B)(4) ON 05/10/2017. THE REPORT STATED THE DEVICE WAS REPAIRED AND SENT BACK TO THE CUSTOMER ON (B)(4) 2017. THE REPAIR INCLUDED REPLACEMENTS OF THE FOLLOWING COMPONENTS: U/D AND R/L PULLEYS; ANGULATION WIRE; ADJUSTMENT COLLAR; FLEXIBLE SHEATH. THE REPORT ALSO STATED, "THE WORN/BROKEN PARTS MAY CONTRIBUTE TO THE KNOBS BEING STIFF AND THE REPAIR SHOULD CORRECT THE ISSUE. THE EQUIPMENT WILL HAVE TO BE INSPECTED BEFORE EACH USE AND IF THE EQUIPMENT FAILS THE INSPECTION AT ANY POINT THEN THE CUSTOMER WILL HAVE TO SEND THE ENDOSCOPE IN FOR INSPECTION/REPAIR. NO OTHER COMPLAINTS HAVE BEEN RECEIVED BY ANY OTHER ACCOUNT WITH REGARDS TO THE KNOBS BEING STIFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196920 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC38-I10L

    Patients

    Seq Age Sex Outcome Treatment
    1