Catalog Number 004551004 |
Device Problem
Break (1069)
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Patient Problem
No Information (3190)
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Event Date 01/10/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Additional information requested by teleflex.No response received to date.
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Event Description
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Customer complaint alleges "the clear plastic part at the bottom of the blade broke at the level of the connection with the handle." no other information was reported.
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Manufacturer Narrative
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(b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the light guide of blade was broken from the base.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturer reports that the device is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.It seems as though the device sustained unexplained physical damage.
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Event Description
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Customer complaint alleges "the clear plastic part at the bottom of the blade broke at the level of the connection with the handle." no other information was reported.
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Search Alerts/Recalls
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