Model Number FNL-10PR3 |
Device Problem
Flare or Flash (2942)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/20/2019 |
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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Pentax medical became aware of a report on 06mar2020 stating, "due to that the scope would produce the high temperature after using a long time, there was no effective isolation, so it caused the cloth liner/placemat was fired.The operating room had heavy smell of the burnt and it would have the risk of the fire.", involving pentax medical fiber naso pharyngo laryngoscope, model fnl-7rp3/serial number (b)(4).Information obtained from report number: (b)(4), the local adverse event report form created on 25oct2019, that was submitted to the (b)(4) food and drug administration (cfda).
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Event Description
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Pentax medical became aware of a report on 06mar2020 stating, "due to that the scope would produce the high temperature after using a long time, there was no effective isolation, so it caused the cloth liner/placemat was fired.The operating room had heavy smell of the burnt and it would have the risk of the fire.", involving pentax medical fiber naso pharyngo laryngoscope, model fnl-10pr3/serial number (b)(4).Information obtained from report number: (b)(4), the local adverse event report form created on 25oct2019, that was submitted to the china food and drug administration (cfda).
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Search Alerts/Recalls
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