Model Number 0502-404-030 |
Device Problems
Crack (1135); Poor Quality Image (1408)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2022 |
Event Type
malfunction
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Event Description
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It was reported that there was blurry image during procedure.
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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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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 "cracked lens" was confirmed.According to henke: scope evaluated as a level 3.Distal tip and fiber damage, cracked on distal lens negative.Probably root cause for this failure is: the complaint for ¿cracked lens¿ has been confirmed and is due to customer use and handling.The reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Event Description
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It was reported that there was blurry image during procedure.
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Search Alerts/Recalls
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