Catalog Number 004551004 |
Device Problem
Break (1069)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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Before opening the package, the user found the blade broken.It appeared the clear part was split in two pieces.The device was unable to be used.No patient involvement reported.
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Event Description
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Before opening the package, the user found the blade broken.It appeared the clear part was split in two pieces.The device was unable to be used.No patient involvement reported.
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Manufacturer Narrative
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(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that the base of light guide is broken.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 also 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.A root cause could not be determined.Due to an increase in complaints for breakage, a capa was opened to further investigate this issue.
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Search Alerts/Recalls
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