KARL STORZ SE & CO. KG ENDOFLATOR 50, W/INTEGRATED SCB MODULE; LAPAROSCOPIC GAS DISTENSION SYSTEM
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Model Number UI500 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190); Device Handling Problem (3265)
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Patient Problem
Insufficient Information (4580)
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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, and one case was converted to open procedure (reference mdr (b)(4)).Customer confirmed that all 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.The total quantity of these cases is unknown and it is also unknown what serial number was involved in any of the cases.Therefore, in addition to mdr (b)(4), we are filing eleven additional reports for each of the customer's other eleven units to represent those cases.This report is the fourth of these additional 11 reports.Customer's 12 'endoflator 50' serial numbers are: (b)(4).
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Manufacturer Narrative
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Per the evaluation findings for serial number po09692, there was no problem found; unit passed all functional tests.
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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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Event Description
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(b)(4).
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Search Alerts/Recalls
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