BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE NEEDLE

    MDR report key: 6021549 · Received October 12, 2016

    Report

    Report Number
    1226420-2016-00153
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    August 22, 2016
    Report Date
    September 13, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K082786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BRIEF DESCRIPTION OF COMPLAINT: DURING ANNUAL PM CHECK BIOMED REPORTS LOW COAG OUTPUT. INVESTIGATION PLAN: VISUAL INSPECTION FUNCTIONAL INSPECTION (IF APPLICABLE) LHR REVIEW COMPLAINT DEVICE DETAILS: DEVICE NAME: PLASMABLADE¿ 4.0 PRODUCT NUMBER: PS200-040 LOT NUMBER: UNKNOWN EXPIRATION DATE: UNKNOWN QUANTITY RETURNED: 1 TESTING PERFORMED: ¿ DEVICE PACKAGING INSPECTION: ¿ ONE RETURNED PLASMABLADE¿ NEEDLE DEVICE WAS RECEIVED INSIDE A MEDTRONIC SHIPPER BOX NOT WITHIN BIOHAZARD BAGS WITH PLASTIC AIR CUSHIONS TO FILL THE NEGATIVE SPACE. ¿ THERE IS A PRODUCT RETURN DISCREPANCY AS THE PRODUCT RETURNED DOES NOT MATCH THE POPULATED PLI INFORMATION WITHIN GCH AS THERE WAS A PLASMABLADE¿ NEEDLE DEVICE RECEIVED AND NOT A PLASMABLADE¿ 4.0 FOR COMPLAINT INVESTIGATION. ¿ DUE TO THE DEVICE DISCREPANCY, IT IS NEITHER POSSIBLE TO CONFIRM THE DEVICE INFORMATION AGAINST THE INFORMATION AGAINST THE INFORMATION LISTED WITHIN GCH NOR CONFIRM THE DEVICE THAT WAS SENT BACK AS THE REPORTED COMPLAINT DEVICE. ¿ THE TYVEK LID WAS RETURNED; THE DEVICE INFORMATION IS LISTED AS: ¿ RETURNED DEVICE NAME: PLASMABLADE¿ NEEDLE ¿ PRODUCT NUMBER: PS-200-001 ¿ LOT NUMBER: 0007172629 ¿ EXPIRATION DATE: 2017-06 ¿ QUANTITY RETURNED: 1 ¿ THERE WAS NO PAPERWORK PROVIDED. ¿ DEVICE VISUAL INSPECTION: ¿ THE DEVICE APPEARS CLEAN AND USED. ¿ THE RETURNED DEVICE, PLASMABLADE¿ NEEDLE, DOES NOT MATCH THE REPORTED COMPLAINT DEVICE, PLASMABLADE¿ 4.0, LISTED WITHIN GCH. ¿ ALL COMPONENTS APPEAR IN PLACE AND INTACT WITH DAMAGE TO THE ELECTRODE INSULATION COATING. ¿ ADDITIONALLY, IT WAS FOUND THAT THE ELECTRODE IS BENT AND THE INSULATION COATING IS DAMAGED, PEELING AND MISSING IN AN AREAS ON THE BLADE, WITH BARE METAL EXPOSED; FIGURE # 1 THRU FIGURE # 4. ¿ IT IS APPARENT THAT THE BLADE IS BENT AT THE INTERFACE OF THE BLACK HEAT SHRINK AND THE ELECTRODE TIP. DUE TO THE FACT THAT THE BLADE COATING IS A GLASS INSULATOR, IF THE BLADE IS BENT THE GLASS TO METAL ADHESION WILL BE COMPROMISED. ¿ THE DAMAGE TO THE ELECTRODE INSULATION COATING RENDERS THE DEVICE INOPERABLE, UNSAFE FOR USE AND IMPEDES FURTHER FUNCTIONAL INSPECTION. ¿ THERE ARE NO VISUAL SIGNS THAT RELATE TO THE REPORTED COMPLAINT DESCRIPTION. FUNCTIONAL INSPECTION: THE FUNCTIONAL INSPECTION PORTION OF THIS INVESTIGATION WAS NOT PERFORMED BECAUSE THE DEVICE WAS RETURNED DAMAGED WHICH RENDERS THE DEVICE INOPERABLE AND IMPEDES FUNCTIONAL INSPECTION. LHR REVIEW: A REVIEW OF THE LHR IS NOT POSSIBLE FOR THE PLASMABLADE¿ 4.0 BECAUSE THE LOT NUMBER IS LISTED AS UNKNOWN WITHIN GCH AND NO ORIGINAL PACKAGING, WAS RETURNED TO OBTAIN THE DEVICE INFORMATION. A REVIEW OF THE LHR FOR LOT # # 0007172629 REVEALED THERE WERE NO PROBLEMS DURING MANUFACTURING THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT DESCRIPTION. INVESTIGATION CONCLUSION: COMPLAINT NOT CONFIRMED: THE REPORTED ISSUE CONTAINED WITHIN GCH WAS NOT DUPLICATED IN THE LABORATORY ENVIRONMENT. THE DEVICE WAS UNABLE TO BE INVESTIGATED FOR THE REPORTED ISSUE BECAUSE THERE IS DAMAGE TO THE ELECTRODE INSULATION COATING WHICH RENDERS THE DEVICE INOPERABLE, UNSAFE FOR USE. THIS COMPLAINT WILL BE TRACKED AND TRENDED WITHIN GCH. ADDITIONALLY, THE ELECTRODE INSULATION COATING IS DAMAGED WITH BARE METAL EXPOSED. THE FLAKING OF THE ELECTRODE INSULATION COATING CREATES AREAS OF EXPOSED METAL WHICH CAN CAUSE DIMINISHED DEVICE PERFORMANCE. HOWEVER, IT CANNOT BE DETERMINED HOW OR WHEN THE ELECTRODE COATING INSULATION WAS DAMAGED. REFERENCE DOCUMENTS: 42-10-1020 REV. H - WORK INSTRUCTIONS FOR COMPLAINT INVESTIGATIONS - DISPOSABLE DEVICES 31-10-1368 REV. H - PRODUCT SPECIFICATION AND QUALITY PLAN - PLASMABLADE¿ 4.0 70-10-1444 REV. A - PEAK PLASMABLADE¿ 4.0 ¿ IFU 31-10-1367 REV. C ¿ PRODUCT SPECIFICATION AND QUALITY PLAN - PLASMABLADE¿ NEEDLE 70-10-1446 REV. B ¿ PEAK PLASMABLADE¿ NEEDLE ¿ IFU 70-10-1429 REV. B ¿ PULSAR¿ II GENERATOR ¿ OPERATORS MANUAL 61-10-0017 REV. H - DEVICE BUTTON TACTILE TEST PROCEDURE TEST EQUIPMENT: 6794 PULSAR¿ II - GENERATOR 7058 EEPROM BYPASS CONNECTOR 7213 EEPROM VERIFICATION READER. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING ANALYSIS IT WAS FOUND THAT THE INSULATION COATING ON THE PLASMABLADE DEVICE WAS PEELING AND MISSING IN AREAS ON THE BLADE. THIS DEVICE WAS USED DURING ANNUAL PM TESTING BY THE BIOMEDICAL DEPARTMENT AND THE CUSTOMER COULD NOT CONFIRM IF THEY SCRAPPED THE COATING OFF AT THE TIP OF THE BLADE DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE PATIENT DEMOGRAPHICS ARE NOT APPLICABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671792 PLASMABLADE NEEDLE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS200-001 0007172629

    Patients

    Seq Age Sex Outcome Treatment
    1