BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISHLER MORGAN BIOPSY PUNCH

    MDR report key: 8209907 · Received January 2, 2019

    Report

    Report Number
    1216677-2018-00094
    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-REVIEW DHR. X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS: THE RETURNED 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 (B)(4)). A REVIEW OF 2 YEAR COMPLAINT HISTORY SHOWS SOME SIMILAR COMPLAINTS ON FILE. A REVIEW OF THE DHR (194053) DID NOT FIND ANY ABNORMALITIES. THE INSTRUMENT 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 ISSUE (2 MIL PLASTIC). THIS PARTICULAR INSTRUMENT WAS SHIPPED TO THE CUSTOMER IN MARCH 2017. THE REPORTED COMPLAINT CONDITION IS ATTRIBUTED TO 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: (B)(4). 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". (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
    3789 TISHLER MORGAN BIOPSY PUNCH TISHLER MORGAN BIOPSY PUNCH HFB COOPERSURGICAL, INC. 64-689 5466

    Patients

    Seq Age Sex Outcome Treatment
    1 Other