BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2848701 · Received October 25, 2012

    Report

    Report Number
    2518897-2012-00010
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    August 21, 2012
    Report Date
    October 25, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDF
    PMA / PMN Number
    K093037
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) MEDICAL CENTER INDICATED THAT THEY UTILIZE A THIRD PARTY ORGANIZATION, NOT AN AUTHORIZED PENTAX SERVICE FACILITY, TO SERVICE AND REPAIR THEIR SCOPES. THE COLONOSCOPE (EC-3490LK, S/N (B)(4)) IS A CUSTOMER OWNED COLONOSCOPE WHICH WAS LAST SERVICED BY PENTAX IN (B)(6) 2011. ACCORDING TO THE CUSTOMER, THE SCOPE WAS LAST REPAIRED IN (B)(6) 2012 BY THE 3RD PARTY ORGANIZATION. IT IS THE POSITION OF PENTAX MEDICAL THE REPAIRS TO PENTAX DEVICES SHOULD ONLY BE PERFORMED BY AN AUTHORIZED PENTAX SERVICE FACILITY. IT IS UNK TO PENTAX WHETHER INSTRUMENTS THAT BEAR A PENTAX LABEL AFTER HAVING BEEN SERVICED OR REMANUFACTURED BY UNAUTHORIZED 3RD PARTY ORGANIZATIONS MEET THE INTENDED USE AND ARE WITHIN THE ORIGINAL DEVICE SPECIFICATIONS FOR NEW EQUIPMENT. AS A RESULT, PENTAX HAS NO WAY OF VERIFYING WHETHER THE PERFORMANCE CHARACTERISTICS, INTENDED USE, SAFETY, AND EFFECTIVENESS OF THE INSTRUMENT HAVE BEEN ADVERSELY AFFECTED AS A CONSEQUENCE OF UNAUTHORIZED REPAIRS. BASED ON THE INFO REPORTED BY (B)(6) MEDICAL CENTER, THE PHYSICIAN COULD NOT PASS A SNARE THROUGH THE OPERATION CHANNEL OF THE COLONOSCOPE (EC-3490LK, S/N (B)(4)) DURING THE COLONOSCOPY PROCEDURE PERFORMED ON (B)(6) 2012; THERE WAS NO IMPACT POSED ON THE PT OR USER. IN OUR EXPERIENCE, THE FAILURE OF THIS DEVICE MAY BE CAUSED OR ATTRIBUTED TO EITHER A KINK OR AN OBSTRUCTION IN THE OPERATION CHANNEL OF THE SCOPE. THEREFORE, THE FAILURE OF THIS DEVICE MAY HAVE BEEN CAUSED BY CIRCUMSTANCES OUTSIDE THE CONTROL OF PENTAX MEDICAL AND MOST LIKELY THERE IS NO IMPACT ON THE DESIGN, OR FORM, FIT, OR FUNCTION OF THE DEVICE. HOWEVER, SINCE THE DEVICE IS NOT AVAILABLE FOR EVAL BY PENTAX, THE CAUSE OF THE MALFUNCTION CANNOT BE CONFIRMED. PENTAX CONSIDERS THIS REPORT CLOSED. CONCLUSION: NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    MEDWATCH REPORT ((B)(4)) STATED: PENTAX 1T FLEXIBLE PEDIATRIC COLONOSCOPE. TWO COLONOSCOPES, PEDIATRIC VERSION AND ONE ADULT COLONOSCOPE WERE SEQUENTIALLY INSERTED INTO THE RECTUM WITH THE PT IN THE LEFT LATERAL DECUBITUS POSITION. SCOPE WAS ADVANCED BY FOLLOWING THE LUMEN, PERIODIC WITHDRAWAL, TORQUING AND CHANGE IN POSITION. THE SCOPE WAS ADVANCED TO THE CECUM. THE FIRST TWO SCOPES BOTH BECAME DAMAGED DURING THE PROCEDURE. THE FIRST ONE, SCOPE (EC-3490LK SERIAL #(B)(4)) WAS NOT ABLE TO BE PASSED WITH A SNARE. THE SECOND ONE (EC-3470LK SERIAL #(B)(4)), THE EQUIPMENT BROKE DURING THE PROCEDURE, THE WHEEL SNAPPED ON THE SCOPE. FOR THAT REASON, A THIRD COLONOSCOPE HAD TO BE INSERTED. THE SCOPE WAS ADVANCED TO THE CECUM. PREPARATION WAS POOR THROUGHOUT MAKING ADEQUATE VISUALIZATION IMPOSSIBLE. SEVERE DIVERTICULOSIS WAS SEEN THROUGHOUT. NOTE: SEPARATE MDR'S WILL BE SUBMITTED TO ADDRESS THE TWO SCOPE MALFUNCTIONS REPORTED IN THE ABOVE DESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO COLONOSCOPE FDF PENTAX MEDICAL COMPANY EC-3490LK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR