BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK-SWARTZ DOPPLER PROBE

    MDR report key: 5059374 · Received September 6, 2015

    Report

    Report Number
    1820334-2015-00570
    Event Type
    Injury
    Date Received
    September 6, 2015
    Date of Event
    August 10, 2015
    Report Date
    August 11, 2015
    Manufacturer
    COOK VASCULAR INC
    Product Code
    ITX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: TRANSDUCER, ULTRASONIC, DIAGNOSTIC. (B)(4). EVENT EVALUATION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE WAS NOT RETURNED, NO IMAGES OR LOT NUMBER WERE PROVIDED TO ASSIST IN THE INVESTIGATION. PER THE CUSTOMER REPORT, THE DOPPLER PROBE'S WIRE OR WIRES BROKE WHEN THE DOCTOR ATTEMPTED TO REMOVE THE DEVICE FROM THE PATIENT. A PORTION OF THE DEVICE WAS LEFT IN THE PATIENT BECAUSE THE DOCTOR DID NOT WANT TO CAUSE HARM TO THE PATIENT. THERE IS NO EVIDENCE THAT THE DEVICE CONTAINED A NONCONFORMITY OR WAS MISUSED. BECAUSE THE DEVICE'S LOT NUMBER WAS NOT PROVIDED, MANUFACTURING RECORDS CANNOT BE REVIEWED FOR NONCONFORMITIES. THE PULL FORCE REQUIRED TO REMOVE THE DOPPLER PROBE FROM THE SILICONE CUFF HAS BEEN VALIDATED. THERE IS NO EVIDENCE THE DEVICE WAS MANUFACTURED IN A WAY THAT WOULD EXCEED THE MAXIMUM PULL FORCE. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION. THE IFU CONTAINS A STATEMENT WARNING AGAINST THE USE OF EXCESSIVE FORCE IN REMOVING THE DEVICE. THE DEVICE MAY BE REMOVED SURGICALLY IN CASES WHERE MANUAL REMOVAL IS DIFFICULT. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA) NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # K022649. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A COOK DOPPLER PROBE WAS USED FOR A FREE FLAPS PROCEDURE. THE MORNING AFTER THE PROCEDURE, THE USER ATTEMPTED TO PULL THE PROBE OUT; HOWEVER, THE WIRE BROKE OFF. THERE WAS A VISIBLE WIRE COMING OUT OF THE NECK INCISION. THE USER ATTEMPTED TO PULL IT AGAIN, BUT MET GREAT RESISTANCE. THE WIRE WAS LEFT IN PLACE, RATHER THAN ATTEMPTING TO APPLY MORE FORCE AND PLACING THE ARTERIAL ANASTOMOSIS AT RISK. NO ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WAS PROVIDED.

    Description of Event or Problem · 1

    AFTER THE USE OF A COOK DOPPLER PROBE FOR A FREE FLAPS PROCEDURE. THE MORNING AFTER THE PROCEDURE, THE USER ATTEMPTED TO PULL THE PROBE OUT, HOWEVER THE WIRE BROKE OFF INSTEAD. THERE WAS A VISIBLE WIRE COMING OUT OF THE NECK INCISION. THE USER ATTEMPTED TO PULL IT AGAIN, BUT MET GREAT RESISTANCE. THE WIRE WAS LEFT IN PLACE RATHER THAN ATTEMPTING TO APPLY MORE FORCE AND PLACING THE ARTERIAL ANASTOMOSIS AT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590786 COOK-SWARTZ DOPPLER PROBE ITX COOK VASCULAR INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1