BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABY TISCHLER BIOPSY

    MDR report key: 8815691 · Received July 23, 2019

    Report

    Report Number
    1216677-2019-00206
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    June 17, 2019
    Report Date
    December 17, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF E-COMPLAINT - (B)(4). INVESTIGATION: X-REVIEW DHR. X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: THE INSTRUMENT WAS SENT BACK TO COOPERSURGICAL AS A REPAIR ITEM. THE RETURNED INSTRUMENT WAS REVIEWED BY A SERVICE AND REPAIR TECHNICIAN AND FOUND IN NEED OF SHARPENING AND LUBRICATION (SEE REPAIR ORDER (B)(4). A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS SOME SIMILAR COMPLAINTS ON FILE. PER THE REPAIR ORDER, THE SERIAL NUMBER OF THE INSTRUMENT WAS (B)(6). A REVIEW OF THE DHR (117094) DID NOT FIND ANY ABNORMALITIES FOR THIS ISSUE. THIS PRODUCT IS PURCHASED FROM A SUPPLIER AND IS PACKAGED AT COOPERSURGICAL. AT COOPERSURGICAL INCOMING INSPECTION, EACH INSTRUMENT IS 100% FUNCTIONALLY CHECKED FOR PROPER CUT USING SIMULATED TISSUE (2 MIL PLASTIC). THIS INSTRUMENT WAS SENT TO THE CUSTOMER IN APRIL 2014. THE REPORTED CONDITION IS ATTRIBUTED TO NORMAL WEAR FROM USE. CORRECTION AND/OR CORRECTIVE ACTION: THE INSTRUMENT WAS SHARPENED AND LUBRICATED. THE INSTRUMENT WAS TESTED AND SENT BACK TO THE CUSTOMER. WAS THE COMPLAINT CONFIRMED? YES . PREVENTATIVE ACTION ACTIVITY: COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR ANY TRENDS.

    Description of Event or Problem · 0

    CUSTOMER STATED "NOT CUTTING PROPERLY ON ALL SIDES." REFERENCE REPAIR ORDER # (B)(4). REFERENCE E-COMPLAINT - (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CONDITION REPORTED IS CURRENTLY UNDER INVESTIGATION. A FOLLOW : UP REPORT WILL BE FILED ONCE THE INVESTIGATION HAS BEEN COMPLETED AND THE FINDINGS ARE AVAILABLE. FOLLOW UP FOR ERROR CORRECTION OF REPORT NUMBER FROM 1216677-2018-000206 TO 1216677-2019-00206 AS EVENT REPORTED OCCURED IN 2019 NOT 2018.

    Description of Event or Problem · 1

    CUSTOMER STATED "NOT CUTTING PROPERLY ON ALL SIDES". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613252 BABY TISCHLER BIOPSY BABY TISCHLER BIOPSY HFB COOPERSURGICAL, INC. 64-691 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other