Model Number VNL-1570STK |
Device Problem
Optical Problem (3001)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/16/2021 |
Event Type
malfunction
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Event Description
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The user found the overall image was dark, which affected the doctor's judgment.The device was out of warranty period, and was delivered to manufacturer's engineer for processing.This event occurred at the time of during inspection.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: the scope was repaired by the third party and returned to the hospital.The hospital was not available to provide detailed information.Reminded the hospital that the daily operation and reprocessing procedure of the endoscope should be regulated in accordance with the ifu, which can reduce the occurrence of accidents.Correction information: g6: follow up #1.H2: type of follow up.H4: device manufacture date.H6: coding changed based on the investigation result.
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Search Alerts/Recalls
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