BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE 3.0 WIDE SPATULA

    MDR report key: 4212477 · Received October 30, 2014

    Report

    Report Number
    1226420-2014-00107
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 29, 2014
    Report Date
    December 3, 2014
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    DWG
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # (B)(4). EVALUATION (METHOD, (RESULT), (CAUSE): DEVICE RETURNED TO MANUFACTURER AND ANALYSIS RESULTS PENDING. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS # (B)(4) COMPLAINT CONFIRMED INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMA BLADE 3.0S, PRODUCT NUMBER: (B)(4), LOT NUMBER: FL50820055, EXPIRATION DATE: 06-23-2017. QUANTITY RETURNED: 1 TESTING PERFORMED: DEVICE PACKAGING INSPECTION: PLASMA BLADE 3.0S PINK DEVICE RECEIVED IN A (B)(4) SHIPPER BOX WITH NO PACKAGING TO FILL THE NEGATIVE SPACE AND DOUBLE BAGGED WITHIN BIOHAZARD BAGS. NO ORIGINAL PACKAGING WAS RETURNED THEREFORE IT IS NOT POSSIBLE TO CONFIRM THE DEVICE INFORMATION AGAINST THE INFORMATION THAT IS LISTED IN THE PRODUCT EVENT PAGE WITHIN (B)(4) NOR IS IT POSSIBLE TO CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE. PRINTED E-MAIL WITH DEVICE RETURN INSTRUCTIONS INCLUDED. DEVICE VISUAL INSPECTION: DEVICE IS USED WITH BLOOD ON BODY, HANDLE CORD AND WITHIN THE SUCTION TUBING. ELECTRODE CHARRING AND PEELING OF THE BLADE COATING. ALL COMPONENTS APPEAR IN PLACE AND INTACT. THE ELECTRODE PEELING IS RELATED TO THE COMPLAINT DESCRIPTION. BOTH CUT AND COAG BUTTONS HAVE A DEFINITIVE TACTILE FEEL. FUNCTIONAL INSPECTION: FUNCTIONAL INSPECTION WAS NOT PERFORMED AS THE COMPLAINT FOR PEELING COATING ON TIP WAS ABLE TO BE CONFIRMED BY VISUAL INSPECTION. PERFORMANCE TESTING FOR THE WEAK CUT ISSUE, COMPROMISES THE DEVICE INTEGRITY, WAS NOT PERFORMED AS THE DEVICE TO BE SENT TO FORT WORTH FOR ROOT CAUSE ANALYSIS FOR THE PEELING COATING ON TIP. LHR REVIEW: A REVIEW OF THE LHR FOR LOT # FL50820055 REVEALED THAT THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED FOR THE PEELING COATING ON TIP ISSUE. DURING VISUAL INSPECTION IT WAS OBSERVED THAT THE ELECTRODE INSULATION, TOP LAYER OF THE COATING, WAS PEELED BACK FROM THE ELECTRODE; HOWEVER IT COULD NOT BE DETERMINED WHAT CAUSED THE INSULATION COATING TO PEEL. A LIKELY CAUSE OF THE FAILURE FOR THE WEAK CUT PERFORMANCE ISSUE THAT WAS REPORTED IN THE COMPLAINT DESCRIPTION IS LIKELY RELATED TO THE DEVICE PEELING COATING ON TIP HOWEVER THIS WAS NOT INVESTIGATED SO THAT THE DEVICE COULD BE SENT TO FORT WORTH FOR ROOT CAUSE ANALYSIS AS PERFORMANCE TESTING WOULD HAVE COMPROMISED THE DEVICE'S INTEGRITY FOR FURTHER TESTING OF THE BLADE COATING FAILURE. THE DEVICE HAS BEEN SENT TO MEDTRONIC FORT WORTH, TX FOR ROOT CAUSE ANALYSIS FOR THE BLADE FAILURE ANALYSIS; SEE ATTACHMENT AND BELOW IS A SUMMARY OF THE FINDINGS IN THE INVESTIGATION CONCLUSION. ALL STEPS OF THE MANUFACTURING PROCESS WERE VERIFIED AND FOUND IN COMPLIANCE WITH THE APPLICABLE PROCEDURES / WORK INSTRUCTIONS / INSPECTIONS AND THERE IS NO EVIDENCE THAT THIS COMPLAINT IS RELATED TO A MANUFACTURING PROCESS DEFECT. NO ABNORMALITIES OR NON-CONFORMANCES WERE FOUND IN THE DEVICE HISTORY RECORD OF THE AFFECTED LOTS RELATED TO THE REPORTED COMPLAINT. THE PLASMA BLADE DEVICE WAS MANUFACTURED ACCORDING TO ESTABLISHED MANUFACTURING PROCESSES.

    Description of Event or Problem · 1

    AFTER 1.5 HOURS INTO THE CASE THE COATING ON THE DEVICE TIP BEGAN TO CURL. THE DOCTOR PEELED OFF ONE ENTIRE SIDE OF THE COATING ON THE DEVICE TIP. NO MATERIAL IS BELIEVED TO HAVE FLAKED OFF OR OTHERWISE BEEN LEFT BEHIND DURING THE OPERATION. THERE WAS NO REPORTED PATIENT IMPACT.

    Description of Event or Problem · 1

    AFTER 1.5 HOURS INTO THE CASE THE COATING ON THE DEVICE TIP BEGAN TO CURL. THE DOCTOR PEELED OFF ONE ENTIRE SIDE OF THE COATING ON THE DEVICE TIP. NO MATERIAL IS BELIEVED TO HAVE FLAKED OFF OR OTHERWISE BEEN LEFT BEHIND DURING THE OPERATION. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697120 PLASMABLADE 3.0 WIDE SPATULA ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY PS210-030S FL50820055

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR