BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 4886427 · Received July 1, 2015

    Report

    Report Number
    2518897-2015-00016
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    January 1, 2015
    Report Date
    June 12, 2015
    Manufacturer
    PENTAX CORP.
    Product Code
    GCL
    PMA / PMN Number
    K951198
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PENTAX MEDICAL RECEIVED BIOPSY FORCEPS WITH WINDOWS AND SPIKE MODEL #KH-2422S/ SERIAL # (B)(4) AND A VISUAL INSPECTION WAS PERFORMED ON 06/03/2015. THE VISUAL INSPECTION CONFIRMED BREAKAGE BY THE HANDLE AREA. NO OTHER VISUAL DEFECTS WERE NOTED. GOOD FAITH EFFORT ATTEMPTS WERE MADE TO THE INITIAL REPORTER ON 06/03/2015 AND 06/11/2015 TO CONFIRM DETAILS OF THE EVENT FOR THE INVESTIGATION AND IN ORDER TO BE ABLE TO ASSESS THE EVENT FOR REPORTABILITY. A PHONE CONVERSATION WAS HELD WITH THE INITIAL REPORTER ON (B)(4) 2015 WHO CONFIRMED THAT THE BREAKAGE OCCURRED DURING PROCEDURE AND NO INJURIES TO THE PT OR USER OCCURRED. DUE TO THESE ADDITIONAL DETAILS, THE EVENT WAS DETERMINED TO BE A REPORTABLE EVENT ON (B)(4) 2015. NO OTHER DETAILS SURROUNDING THE EVENT WERE RECEIVED FROM THE INITIAL REPORTER. BASED ON THE INFO RECEIVED FROM THE INITIAL REPORTER AND THE VISUAL INSPECTION PERFORMED BY PENTAX MEDICAL, A ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. THE ONLY POSSIBILITIES ARE TO SUGGEST THE USER APPLIED EXCESSIVE FORCE WHICH RESULTED IN THE BREAKAGE OR THE BREAKAGE WAS A RESULT OF A MFG NON-CONFORMITY. SINCE THE ROOT CAUSE FOR THIS COMPLAINT IS UNK, A CORRECTIVE ACTION REQUEST WAS INITIATED FOR THE MFR, ALONG WITH SENDING THE SAMPLE INVOLVED IN THIS EVENT, TO FURTHER EVALUATE THE PRODUCT AND IMPLEMENT ANY CORRECTIVE ACTIONS, IF NECESSARY. PENTAX MEDICAL HAS NOT RECEIVED ANY OTHER INFO REGARDING THIS EVENT OR THE MEDICAL DEVICE INVOLVED, AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428501 PENTAX BIOPSY FORCEPS WITH WINDOWS AND SPIKE GCL PENTAX CORP. KH-2422S

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK