BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MKEVORKIAN-PACIFIC PUNCH

    MDR report key: 10637032 · Received October 6, 2020

    Report

    Report Number
    1216677-2020-00225
    Event Type
    Malfunction
    Date Received
    October 6, 2020
    Date of Event
    August 28, 2020
    Report Date
    February 9, 2023
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    HFB
    UDI-DI
    00888937017489
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION. REVIEW DHR. INSPECT RETURNED SAMPLES. DISTRIBUTION HISTORY THE COMPLAINT PRODUCT WAS PURCHASED FROM A SUPPLIER, PACKAGED BY CSI IN OCTOBER 2018 UNDER WORK ORDER (B)(4), AND SHIPPED IN OCTOBER 2019. MANUFACTURING RECORD REVIEW DHR19MPG004457 WAS REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. INCOMING INSPECTION REVIEW. IQC RECORD (B)(4), IQC RECORD (B)(4) AND IQC RECORD (B)(4) WERE REVIEWED AND NO NON-CONFORMITIES, RELATED TO THE COMPLAINT CONDITION, WERE NOTED. THESE THREE INCOMING INSPECTION RECORDS WERE DATED JUST PRIOR TO THE OCTOBER 2018 PACKING DATE. ALSO, IT SHOULD BE NOTED THAT EACH INSTRUMENT IS FUNCTIONALLY TESTED FOR A PROPER CUT USING SIMULATED TISSUE (2 MIL PLASTIC). SERVICE HISTORY RECORD. THIS PRODUCT WAS RETURNED TO COOPERSURGICAL SERVICE AND REPAIR DEPARTMENT IN SEPTEMBER 2020 UNDER REPAIR ORDER (B)(4). HISTORICAL COMPLAINT REVIEW. A REVIEW OF THE 2-YEAR COMPLAINT HISTORY SHOWED SIMILAR REPORTED COMPLAINT CONDITIONS. PRODUCT RECEIPT. THIS INSTRUMENT WAS SENT BACK AS A REPAIR ITEM IN SEPTEMBER 2018. VISUAL EVALUATION. THE RETURNED INSTRUMENT WAS REVIEWED BY A SERVICE AND REPAIR TECHNICIAN AND FOUND IN NEED OF SHARPENING (REFERENCE REPAIR ORDER 94862). FUNCTIONAL EVALUATION . THE RETURNED INSTRUMENT WAS SHARPENED. ROOT CAUSE. THE ROOT CAUSE OF THIS ISSUE HAS BEEN ATTRIBUTED TO NORMAL WEAR FROM USE. CORRECTIVE ACTIONS THE COMPLAINT UNIT HAD THE PUNCH SHARPENED AND WAS CLEANED. THE REPAIRED INSTRUMENT WAS RETURNED TO THE CUSTOMER. COOPERSURGICAL WILL CONTINUE TO TREND THIS COMPLAINT CONDITION. NO TRAINING REQUIRED AT THIS TIME. WAS THE COMPLAINT CONFIRMED? YES.

    Description of Event or Problem · 0

    CUSTOMER STATED: "DEFECTIVE - CANNOT OPEN TO UTILIZE. PROVIDER NEEDED TO DO A BIOPSY AND THE FORCEP DID NOT OPEN, IT WAS JAMMED. - PATIENT WAS NOT INJURED DURING THE PROCEDURE". 1216677-2020-00225-1 64-675 KEVORKIAN-PACIFIC PUNCH E-COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    COOPERSURGICAL IS CURRENTLY INVESTIGATING THE REPORTED CONDITION.

    Description of Event or Problem · 1

    CUSTOMER STATED: "DEFECTIVE - CANNOT OPEN TO UTILIZE". "PROVIDER NEEDED TO DO A BIOPSY AND THE FORCEP DID NOT OPEN, IT WAS JAMMED. PATIENT WAS NOT INJURED DURING THE PROCEDURE". REPAIR TECH STATED "CONFIRMED COMPLAINT: SPECULUM LOCKING KNOB STUCK." REFERENCE REPAIR ORDER #: (B)(4). KEVORKIAN-PACIFIC PUNCH 64-675 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097370 MKEVORKIAN-PACIFIC PUNCH KEVORKIAN-PACIFIC PUNCH HFB COOPERSURGICAL, INC. 64-675 1580 00888937017489

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other