BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUWAVE PR XT PROBE 15CM 15GA

    MDR report key: 16638033 · Received March 29, 2023

    Report

    Report Number
    3008769756-2023-00018
    Event Type
    Injury
    Date Received
    March 29, 2023
    Date of Event
    January 7, 2023
    Report Date
    March 29, 2023
    Manufacturer
    NEUWAVE MEDICAL, INC.
    Product Code
    NEY
    UDI-DI
    00853719006401
    PMA / PMN Number
    K160936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PC-(B)(4). DATE SENT: 5/15/2023. THE ATTACHED PHOTO WAS REVIEWED. IT DISPLAYED A PROBE WITH A BROKEN TIP. THE SERIAL NUMBER OF THIS PROBE IS NOT DISCLOSED IN THE IMAGE. THE OTHER PHOTO WAS A CT IMAGE. INVESTIGATION SUMMARY CALL HOME REVEALED REFLECTED POWER ERRORS. THE PROBE WAS RETURNED TO NEUWAVE AND THE BROKEN PROBE TIP WAS VERIFIED. THE TIP WAS NOT INCLUDED WITH THE PROBE. THE POTENTIAL CAUSE OF THE BROKEN PROBE TIP IS UNKNOWN SINCE NO FURTHER INFORMATION IS AVAILABLE. A SEARCH OF NONCONFORMITIES (NCS) WAS PERFORMED FOR LOT ML22077913. THERE WAS ONE NC FOR THIS LOT- NR-0183491 FOR THE TYVEK HAVING THE INCORRECT LOT NUMBER. THIS ISSUE IS UNRELATED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/20/2023. PHOTO IMAGES WERE RECEIVED AND ARE PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE ABLATION PROCEDURE? LIVER ABLATION. WAS ANY RESISTANCE OR HARD OBJECT, SUCH AS BONE OR CARTILAGE, ENCOUNTERED DURING INSERTION OF THE PROBE? NO THERE WAS NOT, THAT IS WHAT IS BIZARRE. THE CHIEF EVEN REVIEWED ALL THE CT SCANS TO CHECK FOR THIS AS WELL. WAS THERE ANY LATERAL FORCE APPLIED ON THE PROBE DURING INSERTION? NOT TO MY KNOWLEDGE. HOW DID THE SURGEON IDENTIFY THE BROKEN PROBE AND PLEASE DESCRIBE THE STEPS LEADING UP TO IT? WE KEPT GETTING A REFLECTIVE POWER ERROR AND IT LITERALLY BROKE OFF DURING MID ABLATION. WERE THERE ANY ERROR MESSAGING ON THE SYSTEM DURING THE PROCEDURE? YES, REFLECTIVE POWER ERROR, WE KEPT TRYING TO TROUBLE SHOOT AND THEN WHEN WE DID A CT SCAN WE SAW THE TIP IN THE PATIENTS TISSUE UNDER CT. WHAT IS THE APPROXIMATE SIZE OF BROKEN PIECE RETAINED? A FEW CM IS THERE A PLAN FOR THE PROBE PIECE TO BE REMOVED IN THE FUTURE? NO, AS OF NOW THE PATIENT IS FINE AND ANTIBIOTICS WERE PROVIDED. WAS THE PATIENT'S CARE ALTERED IN ANY WAY DUE TO THE BROKEN PROBE AND RETAINED PIECE? NO, BUT THE ABLATION WAS NOT FINISHED. IN THE USER¿S OPINION, WHAT COULD CAUSED OR CONTRIBUTED TO THE PROBE BREAK? THE USER THOUGHT MAYBE CO2 POWER BUT NO ERRORS ON THE SYSTEM AND PREVENTATIVE MAINTENANCE WAS DONE AND SYSTEM IS CHECKED OUT FINE. WHAT IS THE PATIENT'S CURRENT STATUS? UNKNOWN.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: (B)(6) 2023. BATCH #: UNKNOWN. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE, NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT: WHAT WAS THE ABLATION PROCEDURE? WHAT WAS THE APPROACH FOR THE PROBE INSERTION? WAS ANY RESISTANCE OR HARD OBJECT, SUCH AS BONE OR CARTILAGE, ENCOUNTERED DURING INSERTION OF THE PROBE? WAS THERE ANY LATERAL FORCE APPLIED ON THE PROBE DURING INSERTION? HOW DID THE SURGEON IDENTIFY THE BROKEN PROBE AND PLEASE DESCRIBE THE STEPS LEADING UP TO IT? WERE THERE ANY ERROR MESSAGING ON THE SYSTEM DURING THE PROCEDURE? WHAT IS THE APPROXIMATE SIZE OF BROKEN PIECE RETAINED? IS THERE A PLAN FOR THE PROBE PIECE TO BE REMOVED IN THE FUTURE? WAS THE PATIENT'S CARE ALTERED IN ANY WAY DUE TO THE BROKEN PROBE AND RETAINED PIECE? IN THE USER¿S OPINION, WHAT COULD CAUSED OR CONTRIBUTED TO THE PROBE BREAK? WHAT IS THE PATIENT'S CURRENT STATUS? ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION IS PENDING FOR THE FINISHED DEVICE LOT NUMBER THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ABLATION THE TIP OF THE PROBE BROKE OFF WITHIN THE PATIENT AND WAS UNABLE TO BE RETRIEVED. THE PATIENT HAS BEEN TRANSFERRED TO SURGERY AND IS CURRENTLY THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386520 NEUWAVE PR XT PROBE 15CM 15GA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY NEUWAVE MEDICAL, INC. ML22077913 00853719006401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other