BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK

    MDR report key: 5089090 · Received September 18, 2015

    Report

    Report Number
    2523190-2015-00094
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 15, 2015
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 11/11/2015 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - FAILURE ANALYSIS CANNOT BE COMPLETED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. DEVICE HISTORY EVALUATION - DHR REVIEW. NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY: THERE IS NO APPLICABLE NONCONFORMING PRODUCT REPORT / NONCONFORMING MATERIAL REPORT HISTORY. VARIANCE AUTHORIZATION / DEVIATION HISTORY: THERE IS NO APPLICABLE VARIANCE AUTHORIZATION / DEVIATION HISTORY. ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY. CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE. HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: ROOT CAUSE CANNOT BE DETERMINED DUE TO THE LACK OF INFORMATION RECEIVED TO PERFORM A COMPLETE INVESTIGATION. PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS DEVICE WAS STICKING IN PLACE DURING PROCEDURES. (B)(6) 2015 CUSTOMER REPORTS THAT - "OUR FIRST TIME USING THE NEW TISCHLER, DOCTOR TRIED TO BIOPSY PATIENT. THE FORCEP WOULD NOT CLAMP DOWN AND HE WAS UNABLE TO GET A GOOD BIOPSY BECAUSE HE COULDN'T SEPARATE THE TISSUE FROM THE CERVIX. DOCTOR HAD TO MANUALLY OPEN THE TISCHLER WITH THE HANDLE AND ANOTHER TISCHLER WAS USED FOR THE BIOPSY. THE DEVICE WILL NOT OPEN ON ITS OWN. IT WAS UNCOMFORTABLE FOR THE PATIENT DURING THE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619619 TISCHLEY BPSY FCPS 9-1/4IN WITH LOCK PFM07 HFB INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR