Catalog Number 3572-1 |
Device Problem
Calibration Problem (2890)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Udi number: ni.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check.There are no specific surgical procedures associated with this handle.
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Manufacturer Narrative
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Udi number: na.Additional information: (method, results, conclusions) - the returned torque handle was evaluated.Testing results from the supplier found that the device performs within the performance specification and no other issues could be found.As such, the complaint is not confirmed.
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Event Description
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It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check.There are no specific surgical procedures associated with this handle.
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Search Alerts/Recalls
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