Catalog Number 8065990739 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/15/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device history records (dhr) for the device were reviewed.The associated device was released based on acceptance criteria.Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.No udi required due to this device was out of production prior to the september 24, 2014 udi regulation date.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported a secondary energy too low error occurred in the middle of treatment.The surgeon paused the treatment because the patient kept looking around; as soon as the treatment was paused, the error occurred.The error was cleared and the treatment was completed with no patient harm.The patient was noted as doing great postoperatively.
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Manufacturer Narrative
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Returned sample was inspected and shows foot switch is working normal and showing no problem.A technical root cause could be excluded, failure analysis foot switch is working as intended and met specifications.(b)(4).
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Manufacturer Narrative
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During a onsite visit the fse (field service engineer) replaced foot switch and instructed customer on proper pedal technique.The fse successfully completed system verification to specification.A root cause can not determined.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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