Model Number EPK-I7010 |
Device Problems
Detachment of Device or Device Component (2907); Optical Problem (3001); Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/06/2023 |
Event Type
malfunction
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Event Description
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Customer reported when testing the equipment, the video image is too bright.This event occurred at the time of installation.There was no report of patient harm.
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Manufacturer Narrative
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If additional information becomes available, a supplemental report will be filed with the new information.
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Manufacturer Narrative
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Evaluation summary: according to the contents of the report, it was speculated that the fitting of the connection part of the product became loose due to unintended usage (used to connect an aer that delivers a high-temperature disinfectant solution and an endoscope), and that the tube came off when the product was subsequently removed.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.
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Manufacturer Narrative
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Evaluation summary: it was assumed that the feather diaphragm could not be controlled due to temporary dimming failure caused by abnormal operation of the feather diaphragm (iris) due to an accidental failure of the process board (e.G., temperature rise in the processor).A device history record(dhr) review was performed by the manufacturer.The dhr review confirmed the endoscope was manufactured on 28-apr-2022 under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed on 29-apr-2022.
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Search Alerts/Recalls
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