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Catalog Number 28168-59 |
Device Problem
Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference case- (b)(4).
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Event Description
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It was reported that the quantum displayed an e8 wand error.No significant delay.It is unknown if there was a back up available or if the event happen during surgery.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.
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Manufacturer Narrative
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The unit used in treatment, was returned for evaluation.There was no relationship found between the returned device and the reported incident.A review of the device history records show there are no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was a repeat issue.Visual inspection of the rf12000, q2 controller s/n:(b)(6) the warranty seal is broken; the unit was previously opened.The manufacturing date of the controller is rev.Q ¿ 2016.No visible manufacturing abnormalities were found; during functional evaluation the quantum 2 controller was powered on and the error message e-5 immediately appeared ¿ not as reported- with an acoustical alarm sound and a red attention led; failure message could not be reset; the complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.
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Search Alerts/Recalls
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