Model Number 0502-444-030 |
Device Problems
Poor Quality Image (1408); Optical Problem (3001)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that there was a blurry image.
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Manufacturer Narrative
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This scope was not received for evaluation at stryker endoscopy.This scope was received at henke for evaluation.Based on the henke service record attached, the reported failure [blurry] was confirmed.According to henke: scope evaluated as a level 3.Tip and fiber damage, cracked and scratches on distal lens negative.Probably root cause for this failure is: customer use and handling.The failure mode will be monitored for future reoccurrence.The manufacture date is not known.
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Event Description
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It was reported that there was a blurry image.
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Search Alerts/Recalls
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