BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR PULSAR II

    MDR report key: 6012299 · Received October 7, 2016

    Report

    Report Number
    1226420-2016-00148
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 9, 2016
    Report Date
    September 9, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4):BRIEF DESCRIPTION OF COMPLAINT: DURING USE, THE SURGEON IN THIS CASE WAS SHOCKED IN THEIR HAND. THE PATIENT'S GOWN MAY HAVE BEEN BURNED ALSO. COMPLAINT DEVICE DETAILS: PRODUCT CODE (CFN): PS100-102 SERIAL: (B)(4) TESTING PERFORMED: VISUAL INSPECTION: PACKAGING: GENERATOR WAS RETURNED IN AN APPROVED MAE BOX WITH PROPER FOAM PROTECTION. THE PACKAGING DID NOT APPEAR TO HAVE SUSTAINED DAMAGE DURING TRANSIT. EXTERNAL VISUAL: THERE WAS NO EVIDENCE OF EXTERNAL DEFECTS TO THE GENERATOR. INTERNAL VISUAL: THERE WAS NO EVIDENCE OF INTERNAL DEFECTS TO THE GENERATOR. FUNCTIONAL INSPECTION OF GENERATOR RELATED TO REPORTED ISSUE(S): TEST(S) PERFORMED IN ACCORDANCE WITH REPORTED ISSUE: SAFETY TEST, FUNCTIONAL TEST, AND POWER OUTPUT TEST USING THE PULSAR 2 PM FORM - PEARSON METHOD ARE MEASUREMENTS WITHIN SPECIFICATION?: YES EQUIPMENT USED FOR TESTING: 7214, 6327, 6328, PS200-040, 90-1520 RESULTS OF EACH TEST PERFORMED: GENERATOR PASSED ALL SAFETY TESTS. ALL POWER OUTPUTS ARE WITHIN SPECIFICATION AS SHOWN IN CHART 1. DESCRIBE DEFECT FOUND AND IMPACT TO FUNCTIONALITY: NO DEFECTS FOUND DURING SAFETY TESTS, FUNCTIONAL TESTS, AND POWER OUTPUT TESTS DESCRIBE RESOLUTION OF DEFECT (FIX): NO REPAIRS NECESSARY. WERE THERE ADDITIONAL FAILURES FOUND? NO SLHR REVIEW: THIS GENERATOR HAS NOT BEEN IN FOR SERVICE PRIOR TO THIS COMPLAINT. INVESTIGATION CONCLUSION: THE REPORTED ISSUE WAS NOT CONFIRMED. REFERENCE DOCUMENTS: COMPLAINT ANALYSIS-GENERATORS-WORK INSTRUCTIONS 42-10-1119 REV B PULSAR 2 SERVICE PROCESS INSTRUCTIONS 61-10-5631 REV G PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER, HOWEVER THE FOLLOWING SURGEON INFORMATION WAS PROVIDED: WEIGHT: (B)(6) AGE: (B)(6) GENDER: MALE.

    Description of Event or Problem · 1

    DURING A BREAST ONCOLOGY CASE, THE SURGEON REPORTED HIS HAND WAS SHOCKED BY THE PLASMABLADE DEVICE. THERE WAS NO REPORT OF THE DEVICE COMING IN CONTACT WITH METAL; HOWEVER IT COULD NOT BE CONFIRMED. NO INTERVENTIONS WERE NEEDED FOR THE SURGEON AND THERE WAS NO IMPACT TO THE PATIENT. THIS WAS REPORTED IN TWO CASES WITH THE SAME SURGEON. THIS IS CASE 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663454 GENERATOR PULSAR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1