Catalog Number 09-23201 |
Device Problems
Break (1069); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2015 |
Event Type
malfunction
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Event Description
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It was reported that a customer purchased 6 elevators from stryker to use in their oral surgery department, which opened for business less than a year ago.All of their tips have either bent, chipped or broken during use.No adverse consequences were reported.
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Manufacturer Narrative
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The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
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Manufacturer Narrative
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The reported event that the tip of the device has bent could be confirmed.The visual examination revealed that the tip of the device is bent compared to its original shape and shows several deformations due to mechanical overload.Both the dhr review and the hardness measurement performed showed that the device was manufactured according to specification.Most likely too high bending forces were applied to the tip during usage, leading to a deformation.Therefore the root cause can be tied to a user related issue.Indications for any material, manufacturing or design related problems were not determined in the investigation.
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Event Description
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It was reported that a customer purchased 6 elevators from stryker to use in their oral surgery department, which opened for business less than a year ago.All of their tips have either bent, chipped or broken during use.No adverse consequences were reported.
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Search Alerts/Recalls
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