BEUDAMED
    FDA Adverse Event Other Summary report: N

    RINGANCHOR BALLOON SET

    MDR report key: 1604262 · Received February 3, 2010

    Report

    Report Number
    9611612-2010-00001
    Event Type
    Other
    Date Received
    February 3, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 20, 2010
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    GCJ
    PMA / PMN Number
    K090631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAILURE COULD NOT BE DUPLICATED. THE INFO SUPPLIED WAS NOT SUFFICIENT TO CLEARLY IDENTIFY THE ROOT CAUSE. FINAL INSPECTION INCLUDES A 100% CONTROL OF LEAK TIGHTNESS. INITIAL REPORTER ASKED FOR REPLACEMENT DEVICE / REIMBURSEMENT. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IN ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. IF NO FURTHER INFO BECOMES AVAILABLE, PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    INTERNAL REPORT NUMBER FOR REFERENCE: (B)(4). EVENT HAS BEEN REPORTED TO (B)(6) AUTHORITIES AND TOOK PLACE IN (B)(6). DISPOSABLE RINGANCHOR BALLOON SET FOR LAPAROSCOPY: AT THE CONNECTION VALVE / COCK AN AIR LEAKAGE WAS DETECTED. NO RATIONALE OR DESCRIPTION WAS GIVEN IF THIS HAPPENED BEFORE OR DURING INTERVENTION. PT'S STATE HAS NOT BEEN IDENTIFIED. THE DEVICE WILL BE SENT TO MFR FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RINGANCHOR BALLOON SET LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ PAJUNK GMBH MEDIZINTECHNOLOGIE 1285-40-11 811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other