Model Number 0502-414-070 |
Device Problems
Crack (1135); Insufficient Information (3190)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/20/2022 |
Event Type
malfunction
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Event Description
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It was reported that the procedure was cancelled.The patient was under anesthesia, but no incision was made.
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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 the procedure was cancelled.The patient was under anesthesia, but no incision was made.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.According to henke: scope evaluated as a level 3.Distal tip and fiber damaged, broken lenses in system and cracked and scratches on distal lens negative.Probably root cause for this failure is: the complaint for ¿lens cracked¿ has been confirmed and is due to customer use and handling.The device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.
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Search Alerts/Recalls
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