BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5499220 · Received March 14, 2016

    Report

    Report Number
    9610877-2016-00070
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    October 8, 2013
    Report Date
    October 14, 2013
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    PMA / PMN Number
    REFER TO H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PRODUCT CODE IS CLASS 1, THEREFORE THIS DEVICE MODEL IS EXEMPT FROM FDA 510(K). MDR 9610877-2016-00070 IS BEING SUBMITTED FOR PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0051063. MDR 9610877-2016-00079 IS BEING SUBMITTED FOR PENTAX GASTROSCOPE MODEL EG-2985K/SERIAL (B)(4). THIS MDR WAS INITIATED AS PART OF A CAPA-DRIVEN REMEDIATION EFFORT RELATED TO FILING OF MDR'S FOR COMPLAINTS/EVENTS OUTSIDE OF THE US (OUS). AS PART OF THIS REMEDIATION, PENTAX MEDICAL PERFORMED A RETROSPECTIVE MDR ASSESSMENT OF ALL OUS EVENTS/COMPLAINTS RECEIVED SINCE JAN 2013. THE RETROSPECTIVE ASSESSMENT OF THIS EVENT PROMPTED PENTAX MEDICAL TO FILE THIS REPORT. (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN (B)(6) STATING WHILE PERFORMING A PROCEDURE WITH PENTAX GASTROSCOPE MODEL EG- 2985K/SERIAL (B)(4) A PIECE OF A PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0051063 WAS FOUND IN THE STOMACH OF THE PATIENT. THE DISTAL PORTION OF THE BRUSH RETRIEVED FROM THE PATIENT WAS FORWARDED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER PERFORMED A VISIBLE INSPECTION WITH THE FOLLOWING RESULTS: "CONSIDERING THE TOTAL LENGTH OF THE RETURNED PRODUCT WAS 119MM AND THE LENGTH OF THE DISTAL PORTION OF THE BRUSH ON THE DRAWING (POM TUBE+ BRUSHX3 + SUS) IS 117MM ( +22/ -16), IT IS DIFFICULT TO THINK THAT IT WAS CUT OFF IN THE MIDDLE. SINCE THE TIP OF STAINLESS PART HAD A SHAPE LOOKS LIKE IT HAD BEEN CUT OFF BY A NIPPER, IT CAN BE PRESUMED THAT THE RETURNED BRUSH PART HAS BEEN PULLED OUT FROM THE POM TUBE AND NOT BEEN CUT OFF/BROKEN IN THE MIDDLE OF STAINLESS PART. A LITTLE AMOUNT OF SOMETHING LIKE ADHESION GLUE WAS ATTACHED TO THE RETURNED PRODUCT." THE MANUFACTURER PERFORMED A REPRODUCTION TEST WITH THE FOLLOWING RESULTS: "WHEN PULLING IT WITH THE EXCESSIVE FORCE, EITHER THE SUS BROKE OR POM TUBE BROKE BEFORE THE BRUSH PART COMES OFF FROM THE POM TUBE. IN OTHER WORDS, IT IS DIFFICULT TO THINK THAT THE BRUSH PART CAN BE PULLED OFF SMOOTHLY FROM POM TUBE EVEN IF IT'S BEEN PULLED WITH THE EXCESSIVE FORCE." THE MANUFACTURER CONCLUDED "ALTHOUGH WE DO NOT FIND THE CLEAR CAUSE, IT ASSUME THAT THIS WOULD HAVE CAUSED DUE TO THE INSUFFICIENT GLUE OR REPEATED EXCESSIVE LOAD WOULD HAVE MADE THE ADHESION STRENGTH OF THE DISTAL PART DECREASE BY USING A DISPOSAL PRODUCT REPEATEDLY, THE ADHESION STRENGTH OF THE DISTAL PART DECREASED AND IT CAME OFF." IN ADDITION, THE DEVICE HISTORY RECORD AND SHIPMENT INSPECTION RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, THEREFORE PENTAX MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154519 PENTAX CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS-6021T 0051063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention