BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK VAPR COOLPULSE 90 ELECTRODE

    MDR report key: 3925526 · Received July 10, 2014

    Report

    Report Number
    1221934-2014-00286
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    May 27, 2014
    Report Date
    June 11, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    GEI
    PMA / PMN Number
    K100638
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION ABOUT THE EVENT AND DEVICE. THE ADDITIONAL INFORMATION WILL REPORTEDLY BE FORWARDED TO DEPUY MITEK HOWEVER IT IS NOT KNOWN IF IT WILL BE RECEIVED WITHIN THE 30 DAY REPORTING REQUIREMENT, THEREFORE DEPUY MITEK WOULD LIKE TO FILE THIS INITIAL MEDWATCH REPORT AT THIS TIME. WHEN AND IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REFLECTED IN A FOLLOW-UP MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION CONFIRMS THE ACTIVE TIP IS BROKEN, THE CABLE IS CUT AND THE CERAMIC ON THE DISTAL TIP SHOWED SIGNS OF ACTIVATION. THERE IS A MARK ON THE CERAMIC WHICH IS CONSISTENT WITH DEVICE COMING INTO CONTACT WITH ANOTHER METALLIC OBJECT DURING USE. IT WAS NOTED THAT THE ACTIVE SUCTION TUBE HAS ERODED DURING USE AND THERE IS A SECTION OF THE ACTIVE SUCTION TUBE WHICH IS BELIEVED TO BE ERODED AWAY DUE TO EXCESSIVE USE AND WOULD NOT HAVE DEPOSITED INTO THE PATIENT JOINT SPACE. NO ELECTRICAL OR FUNCTIONAL TESTS WERE CONDUCTED DUE TO THE CONDITION OF THE ELECTRODE. THIS FAILURE IS BEING INVESTIGATED UNDER SUPPLIER CAPA. FOUR POSSIBLE ROOT CAUSES HAVE BEEN IDENTIFIED RELATED TO DESIGN, MANUFACTURING AND USE. CORRECTIVE ACTIONS WHICH INVOLVE DESIGN AND PROCESS IMPROVEMENT ACTIVITIES WERE IDENTIFIED FOR EACH OF THE ROOT CAUSE AND ARE BEING CURRENTLY INVESTIGATED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A REVIEW INTO THE COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. FURTHER, IN THE PAST 12 MONTHS, THERE WERE (B)(4) OTHER COMPLAINTS NOTED WITH THE SAME FAILURE AND ROOT CAUSE. THE OBSERVED COMPLAINT RATE IS (B)(4) AND IS WELL BELOW THE EXPECTED RATE OF (B)(4) PER THE RISK ASSESSMENT. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION CONFIRMS THE ACTIVE TIP IS BROKEN, THE CABLE IS CUT AND THE CERAMIC ON THE DISTAL TIP SHOWED SIGNS OF ACTIVATION. THERE IS A MARK ON THE CERAMIC WHICH IS CONSISTENT WITH DEVICE COMING INTO CONTACT WITH ANOTHER METALLIC OBJECT DURING USE. IT WAS NOTED THAT THE ACTIVE SUCTION TUBE HAS ERODED DURING USE AND THERE IS A SECTION OF THE ACTIVE SUCTION TUBE WHICH IS BELIEVED TO BE ERODED AWAY DUE TO EXCESSIVE USE AND WOULD NOT HAVE DEPOSITED INTO THE PATIENT JOINT SPACE. NO ELECTRICAL OR FUNCTIONAL TESTS WERE CONDUCTED DUE TO THE CONDITION OF THE ELECTRODE. THIS FAILURE IS BEING INVESTIGATED UNDER SUPPLIER CAPA. FOUR POSSIBLE ROOT CAUSES HAVE BEEN IDENTIFIED RELATED TO DESIGN, MANUFACTURING AND USE. CORRECTIVE ACTIONS WHICH INVOLVE DESIGN AND PROCESS IMPROVEMENT ACTIVITIES WERE IDENTIFIED FOR EACH OF THE ROOT CAUSE AND ARE BEING CURRENTLY INVESTIGATED. A BATCH RECORD REVIEW HAS BEEN CONDUCTED AND OUR RESULTS INDICATE THAT THIS BATCH OF PRODUCT WAS PROCESSED WITHOUT INCIDENT AND THEREFORE THERE IS NO INTERNALLY ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM. A REVIEW INTO THE COMPLAINTS SYSTEM REVEALED NO OTHER COMPLAINT FOR THIS LOT OF DEVICES THAT WERE RELEASED TO DISTRIBUTION. FURTHER, IN THE PAST 12 MONTHS, THERE WERE 9 OTHER COMPLAINTS NOTED WITH THE SAME FAILURE AND ROOT CAUSE. (B)(4). MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    THE ELECTRODE CARBONIZED THE OPTICS USED SIMULTANEOUSLY THE ELECTRODE VAPR ARTHROSCOPY USED TO MAKE THE ELECTROSPRAY BURNED THE OPTICAL. AND DURING THE LAST USE, A PIECE OF ELECTRODE IS BROKE AND FELL INTO THE PATIENT'S SHOULDER. THE PIECE OF ELECTRODE WAS RETRIEVED BY THE SURGEON. ADDITIONAL INFORMATION FROM THE AFFILIATE 6-16-14 HOW LONG DID THIS ISSUE EXTEND THE PROCEDURE TIME, MORE THAN 30 MINUTES? NO, LESS THAN 30 MINUTES. HOW LONG WAS THE ELECTRODE ACTIVATED? FEW MINUTES. WAS ELECTRODE BURIED IN TISSUE? YES. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 6-20-14; THE PROCEDURE WAS EXTENDED FOR A FEW MINUTES, LESS THAN 30 MINUTES DUE TO THE ISSUES WITH THE COMPLAINT DEVICE. THE COMPLAINT DEVICE ELECTRODE DID NOT SPARK AND ARC. THE SURGEONS VISION WAS IMPAIRED DURING THE PROCEDURE DUE TO THE BLACKENING OF THE OPTICS. THE VAPR GENERATOR HAD THE CURRENT REVISION SOFTWARE. THE VAPR GENERATOR DID NOT ALWAYS GIVE AN OUTPUT SHORTED ALARM IN THE CASE, IT SEEMED TO DEPEND ON THE ANGLE OF APPROACH. THEY CONTINUED USE OF THE ELECTRODE WITHOUT SPECIFIC ACTIONS. THE METAL PART OF THE TIP BROKE OFF AND FELL INTO THE PATIENT. THE ELECTRODE HAD BEEN BURIED IN TISSUE, AND NO INFORMATION WAS AVAILABLE AS TO HOW LONG IT HAD BEEN ACTIVATED. THERE WAS NO INFORMATION AVAILABLE AS TO WHETHER OR NOT THE COMPLAINT DEVICE HAD BEEN RE-PROCESSED PRIOR TO USE IN THE PROCEDURE.

    Description of Event or Problem · 1

    THE ELECTRODE CARBONIZED THE OPTICS USED SIMULTANEOUSLY. THE ELECTRODE VAPR ARTHROSCOPY USED TO MAKE THE ELECTROSPRAY BURNED THE OPTICAL. AND DURING THE LAST USE, A PIECE OF ELECTRODE IS BROKE AND FELL INTO THE PATIENT'S SHOULDER. THE PIECE OF ELECTRODE WAS RETRIEVED BY THE SURGEON. ADDITIONAL INFORMATION FROM THE AFFILIATE 6-16-14 HOW LONG DID THIS ISSUE EXTEND THE PROCEDURE TIME, MORE THAN 30 MINUTES? NO, LESS THAN 30 MINUTES. HOW LONG WAS THE ELECTRODE ACTIVATED? FEW MINUTES. WAS ELECTRODE BURIED IN TISSUE? YES. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON 6-20-14; THE PROCEDURE WAS EXTENDED FOR A FEW MINUTES, LESS THAN 30 MINUTES DUE TO THE ISSUES WITH THE COMPLAINT DEVICE. THE COMPLAINT DEVICE ELECTRODE DID NOT SPARK AND ARC. THE SURGEONS VISION WAS IMPAIRED DURING THE PROCEDURE DUE TO THE BLACKENING OF THE OPTICS. THE VAPR GENERATOR HAD THE CURRENT REVISION SOFTWARE. THE VAPR GENERATOR DID NOT ALWAYS GIVE AN OUTPUT SHORTED ALARM IN THE CASE, IT SEEMED TO DEPEND ON THE ANGLE OF APPROACH. THEY CONTINUED USE OF THE ELECTRODE WITHOUT SPECIFIC ACTIONS. THE METAL PART OF THE TIP BROKE OFF AND FELL INTO THE PATIENT. THE ELECTRODE HAD BEEN BURIED IN TISSUE, AND NO INFORMATION WAS AVAILABLE AS TO HOW LONG IT HAD BEEN ACTIVATED. THERE WAS NO INFORMATION AVAILABLE AS TO WHETHER OR NOT THE COMPLAINT DEVICE HAD BEEN RE-PROCESSED PRIOR TO USE IN THE PROCEDURE.

    Description of Event or Problem · 1

    THE ELECTRODE CARBONIZED THE OPTICS USED SIMULTANEOUSLY. THE ELECTRODE VAPR ARTHROSCOPY USED TO MAKE THE ELECTROSPRAY BURNED THE OPTICAL. AND DURING THE LAST USE, A PIECE OF ELECTRODE IS BROKE AND FELL INTO THE PATIENT'S SHOULDER. THE PIECE OF ELECTRODE WAS RETRIEVED BY THE SURGEON. ADDITIONAL INFORMATION FROM THE AFFILIATE (B)(4) 2014 HOW LONG DID THIS ISSUE EXTEND THE PROCEDURE TIME, MORE THAN 30 MINUTES? NO, LESS THAN 30 MINUTES. HOW LONG WAS THE ELECTRODE ACTIVATED? FEW MINUTES. WAS ELECTRODE BURIED IN TISSUE? YES. THE FOLLOWING INFORMATION WAS RECEIVED FROM OUR AFFILIATE ON (B)(4) 2014; THE PROCEDURE WAS EXTENDED FOR A FEW MINUTES, LESS THAN 30 MINUTES DUE TO THE ISSUES WITH THE COMPLAINT DEVICE. THE COMPLAINT DEVICE ELECTRODE DID NOT SPARK AND ARC. THE SURGEONS VISION WAS IMPAIRED DURING THE PROCEDURE DUE TO THE BLACKENING OF THE OPTICS. THE VAPR GENERATOR HAD THE CURRENT REVISION SOFTWARE. THE VAPR GENERATOR DID NOT ALWAYS GIVE AN OUTPUT SHORTED ALARM IN THE CASE, IT SEEMED TO DEPEND ON THE ANGLE OF APPROACH. THEY CONTINUED USE OF THE ELECTRODE WITHOUT SPECIFIC ACTIONS. THE METAL PART OF THE TIP BROKE OFF AND FELL INTO THE PATIENT. THE ELECTRODE HAD BEEN BURIED IN TISSUE, AND NO INFORMATION WAS AVAILABLE AS TO HOW LONG IT HAD BEEN ACTIVATED. THERE WAS NO INFORMATION AVAILABLE AS TO WHETHER OR NOT THE COMPLAINT DEVICE HAD BEEN RE-PROCESSED PRIOR TO USE IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403551 MITEK VAPR COOLPULSE 90 ELECTRODE VAPR ELECTRODES GEI DEPUY MITEK NA U1401262

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention