BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISCHLER MORGAN TIP

    MDR report key: 11235939 · Received January 27, 2021

    Report

    Report Number
    1216677-2021-00008
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    December 21, 2020
    Report Date
    November 14, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION X-REVIEW DHR X-INSPECT RETURNED SAMPLES. ANALYSIS AND FINDINGS DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM A SUPPLIER (HBH-GMBH), PACKAGED BY CSI IN MAY 2020 UNDER WORK ORDER (B)(4), AND SOLD IN NOVEMBER 2020. MANUFACTURING RECORD REVIEW (B)(4) WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW INCOMING INSPECTION PERFORMS 100% FUNCTIONAL CUT TEST ON SIMULATED TISSUE (2 MIL PLASTIC). A REVIEW OF 2 YEAR INCOMING INSPECTION RECORDS DOES NOT SHOW ANY NON-CONFORMITIES RELATED TO THE COMPLAINT CONDITION. SERVICE HISTORY RECORD THIS PRODUCT WAS RETURNED TO THE SERVICE AND REPAIR DEPARTMENT ON 12/29/20 FOR THE PUNCH TIP OCCASIONALLY GETTING CAUGHT WHEN TRYING TO ENGAGE. REPAIR ORDER (B)(4) WAS GENERATED AND THE REPORTED CONDITION WAS CONFIRMED. HISTORICAL COMPLAINT REVIEW A REVIEW OF THE 2-YEAR COMPLAINT HISTORY DID SHOW A COUPLE SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT THE COMPLAINT PRODUCT WAS RETURNED ON 12/29/20. THE LOT NUMBER OF THE RETURNED PRODUCT MATCHED THE LOT NUMBER REPORTED. VISUAL EVALUATION VISUAL EXAMINATION OF THE COMPLAINT PRODUCT REVEALED PHYSICAL DAMAGE ON THE PUNCH TIP. FUNCTIONAL EVALUATION COMPLAINT PRODUCT WAS FUNCTIONALLY EVALUATED AND FOUND NOT TO FUNCTION PROPERLY. THE PUNCH TIP OCCASIONALLY GETS CAUGHT WHEN ATTEMPTING TO ENGAGE. ROOT CAUSE EACH INSTRUMENT IS 100% FUNCTIONALLY TESTED AT INCOMING INSPECTION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE RELIABLY DETERMINED, THE POTENTIAL CAUSE OF THE DAMAGED PUNCH TIP MAY BE RELATED TO HANDLING AFTER LEAVING THE COOPERSURGICAL FACILITY. CORRECTION AND/OR CORRECTIVE ACTION THE RETURNED PRODUCT WAS SCRAPPED AND A REPLACEMENT WAS SENT TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS. PREVENTATIVE ACTION ACTIVITY COOPERSURGICAL WILL CONTINUE TO MONITOR THIS COMPLAINT CONDITION FOR TRENDS.

    Description of Event or Problem · 0

    REF E-COMPLAINT (B)(4). CUSTOMER STATED "FROM BEGINNING OF USE, THE TIP MAY GET CAUGHT AND THE CUSTOMER MAY NOT BE ABLE TO PUNCH WELL. SO THEY WANT A NEW REPLACEMENT." REPAIR TECH STATED "CONFIRMED COMPLAINT - BAD TIP CUTTER - SCRAPPED AND REPLACED W/NEW" REFERENCE REPAIR ORDER (B)(4). INITIAL FOLLOW UP 1/7/2021. 1/11/2021. CUSTOMER RESPONDED 1/12/2021. 1216677-2021-00008 TISCHLER MORGAN TIP 64-484 E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL, INC. IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    REF E-COMPLAINT (B)(4). CUSTOMER STATED "FROM BEGINNING OF USE, THE TIP MAY GET CAUGHT AND THE CUSTOMER MAY NOT BE ABLE TO PUNCH WELL. SO THEY WANT A NEW REPLACEMENT." REPAIR TECH STATED "CONFIRMED COMPLAINT - BAD TIP CUTTER - SCRAPPED AND REPLACED W/NEW" REFERENCE REPAIR ORDER (B)(4). INITIAL FOLLOW UP 1/7/2021 1/11/2021 CUSTOMER RESPONDED 1/12/2021 1216677-2021-00008 TISCHLER MORGAN TIP 64-484 E-COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131160 TISCHLER MORGAN TIP TISCHLER MORGAN TIP HFB COOPERSURGICAL, INC. 64-484

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other