Catalog Number 0250080618 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(b)(4).The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
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Event Description
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It was reported there is a crack in the tip.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: crack in tip.The probable root cause/s could be normal wear, user misuse, and improper sterilization methods.The reported failure mode will be monitored for future reoccurrence.Mfg date: july 13, 2015.(b)(4).
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Event Description
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It was reported there is a crack in the tip.
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Search Alerts/Recalls
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