Model Number 0502477031 |
Device Problems
Poor Quality Image (1408); Nonstandard Device (1420)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2020 |
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 poor image.
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Manufacturer Narrative
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The device was not received for investigation at stryker endoscopy because it was repaired locally in poland.The technical service report is attached, and indicates: broken inner lens, hazy.Probable root cause: poor mate between cannula and endoscope; poor fit between endoscope needle and cannula; use error.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
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Event Description
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It was reported that there was a poor image.
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Search Alerts/Recalls
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