Catalog Number 0220180517 |
Device Problem
No Device Output (1435)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that fibers were not lighting up when inserted into the catheter.The procedure was completed successfully without any adverse consequences.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence alleged failure: it didn¿t work when plugged in the failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be a bent light fiber.Mfg date: manufacture date is not known.(b)(4).
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Event Description
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It was reported that fibers were not lighting up when inserted into the catheter.The procedure was completed successfully without any adverse consequences.
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Search Alerts/Recalls
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