Model Number SI-7501E-03N |
Device Problems
Component Missing (2306); No Apparent Adverse Event (3189)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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An instrument was found to be damaged by a sales representative.It is not known if the instrument was involved in a surgery when it was damaged or if it caused an adverse event for a patient.The device has not been returned at this time.A capa has been initiated for this issue.When more information is available, a supplement report will be submitted.
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Event Description
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A sales representative found an instrument that was disassembled.It is not known if the damage occured during a surgery or if it negatively affected a patient.If more information is discovered, a supplement report will be submitted.
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Manufacturer Narrative
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Capa determined that the design of the device was the likely root cause of the failure.A change is in process to correct the issue.
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Event Description
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There are still no reported harms to patients that have occured due to this failure.
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Search Alerts/Recalls
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