BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISHLER MORGAN BIOPSY PUNCH

    MDR report key: 8209504 · Received January 2, 2019

    Report

    Report Number
    1216677-2018-00093
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    November 9, 2018
    Report Date
    December 29, 2019
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    REF E-COMPLAINT (B)(4). INVESTIGATION: X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: THE INSTRUMENT WAS SENT BACK AS A REPAIR ITEM. THE RETURNED INSTRUMENT WAS REVIEWED BY A SERVICE AND REPAIR TECHNICIAN AND FOUND IN NEED OF SHARPENING (SEE REPAIR ORDER 90569). THIS PRODUCT IS PURCHASED FROM A SUPPLIER AND IS PACKAGED AT COOPERSURGICAL. AT COOPERSURGICAL INCOMING INSPECTION, EACH INSTRUMENT IS FUNCTIONALLY CHECKED FOR A PROPER CUT USING SIMULATED TISSUE (2 MIL PLASTIC). A REVIEW OF TWO YEAR COMPLAINT HISTORY SHOWS SOME COMPLAINTS FOR THIS ISSUE. THE INSTRUMENT DID NOT HAVE A SERIAL NUMBER WHICH INDICATES THE INSTRUMENT WAS PURCHASED PRIOR TO 2010 WHEN COOPERSURGICAL IMPLEMENTED SERIAL NUMBERS. THE INSTRUMENT EXHIBITED NORMAL WEAR FROM USE. CORRECTION AND/OR CORRECTIVE ACTION: THE INSTRUMENT WAS SHARPENED, CLEANED AND LUBRICATED. THE INSTRUMENT MET QUALITY REQUIREMENTS AND WAS RELEASED BACK TO THE CUSTOMER. WAS THE COMPLAINT CONFIRMED? YES. PREVENTATIVE ACTION ACTIVITY MONITOR AND TREND TO CIP.

    Description of Event or Problem · 0

    "PER CUSTOMER'S STATEMENT ON REPAIR AUTHORIZATION FORM " NEEDS SHARPENED & REPAIRED". REFERENCE REPAIR ORDER: 90569. CUSTOMER FURTHER STATED CONCERN "NOT CLOSING COMPLETELY AND RELEASING WHILE CUTTING TISSUE" AS WELL AS " NOT BEING ABLE TO RELEASE FROM TISSUE". 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. (B)(4).

    Description of Event or Problem · 1

    "PER CUSTOMER'S STATEMENT ON REPAIR AUTHORIZATION FORM " NEEDS SHARPENED & REPAIRED". REFERENCE REPAIR ORDER: (B)(4). CUSTOMER FURTHER STATED CONCERN "NOT CLOSING COMPLETELY AND RELEASING WHILE CUTTING TISSUE" AS WELL AS " NOT BEING ABLE TO RELEASE FROM TISSUE". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3619 TISHLER MORGAN BIOPSY PUNCH TISHLER MORGAN BIOPSY PUNCH HFB COOPERSURGICAL, INC. 64-689 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other