Catalog Number B12SRT |
Device Problem
Crack (1135)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/28/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot/batch was not provided, a device history could not be performed.Additional information was requested and the following was obtained: please clarify the part of the device that was cracked.Was the optical element cracked? was the bladeless tip cracked? the edge of the trocar sleeve was cracked.
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Event Description
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It was reported that during a pediatric vats procedure the trocar tip was cracked.Case completed with another device.There were no patient consequences reported.
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Manufacturer Narrative
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(b)(4).Batch # unknown.The analysis results found that the b12srt instrument was received with the sleeve broken and melted.Only the sleeve was returned.This type of damage is consistent with the one produced by an energized device.In order to prevent this kind of damage please avoid the contact with laser, electrosurgical or ultrasonic devices.The reported complaint was confirmed.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance's.
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Search Alerts/Recalls
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