Catalog Number CTB12LT |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/10/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Batch # unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.As a lot/batch was not provided, a device history could not be performed.
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Event Description
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According to surgeon the tip of the sleeve breaks with very little movement of the instruments or while inserting in the abdominal wall with opturator.His concern is about the quality of the product and patient safety.Procedure: unknown.
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Manufacturer Narrative
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(b)(4).Batch # p91c2z device analysis: the analysis results found that the ctb12lt instrument was received with the tip of the sleeve broken and the sleeve cap separated.One potential cause for the damage found may be the inadvertent application of excessive force or torquing during insertion into the abdominal cavity.We have documented the circumstances as they were reported to us.In addition, complaint information is trended on a regular basis to determine if further investigation is warranted.A manufacturing record evaluation was performed for the finished device p91c2z batch number, and no non-conformances were identified.
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Search Alerts/Recalls
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