Catalog Number 0220180517 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/26/2017 |
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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Lighted ureteral stents were not working at the beginning of the procedure then suddenly started working.Although there was patient involvement, there was no adverse consequence.
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Manufacturer Narrative
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The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.Alleged failure: not working properly.Probable root cause: diode failure.Loose/disconnected cable.Cpu pc board defect.Power loss to diode.The device manufacture date is not known.Gtin: (b)(4).
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Event Description
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Lighted ureteral stents were not working at the beginning of the procedure then suddenly started working.Although there was patient involvement, there was no adverse consequence.
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Search Alerts/Recalls
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