Model Number UI500 |
Device Problems
Sensing Intermittently (1558); Insufficient Information (3190); Device Handling Problem (3265)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/18/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation as of yet.
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Event Description
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Per the customer, their twelve 'endoflator 50' units have failed to keep pressure during several cases.One failure during a total laparoscopic hysteroscopy case resulted in having to convert to an open procedure.The customer confirmed that the patient did well post-operatively.They could not say which serial number was involved in this case.Customer confirmed that all of the other cases were completed either by using the same unit, or another unit was brought in; they also confirmed there was no negative patient impact in those cases.We will file eleven additional reports for each of the customer's other eleven units to represent those cases.Customer's 12 'endoflator 50' serial numbers are: (b)(4).
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Manufacturer Narrative
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One of customer's 12 units returned for evaluation (serial #: (b)(6)) was found to have a faulty pressure sensor.Based on the evaluation results, the defective pressure sensor is the most probable root cause of the failure to keep pressure, resulting in the case being converted to an open procedure.
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Event Description
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Complaint id: (b)(4).
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Manufacturer Narrative
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Per the customer, their endoflator 50 units have failed to keep pressure during several cases.Based on the manufacturer's evaluation, the review of the device history record did not show any non-conformity which could have led to the reported issue.According to the evaluation of similar complaints, a product related problem could be excluded.The most probable root cause could be traced back to a use error.When the device will be switched on, a self-test will be performed.Accessories must not be connected until the self-test is done.Otherwise, an error message (error 322) will be displayed.
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Search Alerts/Recalls
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