BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERATOR PULSAR II

    MDR report key: 6124231 · Received November 23, 2016

    Report

    Report Number
    1226420-2016-00183
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    October 25, 2016
    Report Date
    March 31, 2017
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4): BRIEF DESCRIPTION OF COMPLAINT: WHEN THE DEVICE WAS ACTIVATED, THE SURGEON¿S HAND WAS SHOCKED. HE REPORTED A SPARK FROM THE DEVICE. 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, 562, 577, 578 RESULTS OF EACH TEST PERFORMED: GENERATOR PASSED ALL SAFETY TESTS, AND ALL POWER OUTPUTS ARE WITHIN SPECIFICATION. DESCRIBE DEFECT FOUND AND IMPACT TO FUNCTIONALITY: NO DEFECTS FOUND DURING SAFETY TESTS, FUNCTIONAL TESTS OR POWER OUTPUT TESTS. DESCRIBE RESOLUTION OF DEFECT (FIX): NO REPAIRS NECESSARY WERE THERE ADDITIONAL FAILURES FOUND? NO SLHR REVIEW: NO PRIOR SERVICE HISTORY 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 AND SURGEON INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. 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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT: (B)(4). 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 THE CASE, UPON ACTIVATION ON THE PLASMABLADE DEVICE, THE SURGEONS HAND WAS SHOCKED. THE SURGEON ALSO REPORTED A SPARK FROM THE DEVICE. NO INTERVENTIONS WERE NEEDED AND THERE WAS NO HARM TO THE PATIENT.

    Description of Event or Problem · 1

    DURING THE CASE, UPON ACTIVATION ON THE PLASMABLADE DEVICE, THE SURGEONS HAND WAS SHOCKED. THE SURGEON ALSO REPORTED A SPARK FROM THE DEVICE. NO INTERVENTIONS WERE NEEDED AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774449 GENERATOR PULSAR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1