STRYKER ENDOSCOPY-SAN JOSE PKG, INFRAVISION UNIVERSAL URETERAL KIT (BOX OF 5); LIGHT, CATHETER, FIBEROPTIC, GLASS, URETERAL
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Catalog Number 0220180517 |
Device Problem
Optical Problem (3001)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/17/2017 |
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 the stent not properly illuminating.Although there was patient involvement, there was no adverse consequence.
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Manufacturer Narrative
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Alleged failure: bent inside sterile packaging.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could be a shipping error as the sterile packaging is bent.However, upon further investigation and testing, the bent packaging did not cause the product to fail.The product failing could be a result of user error or the customer's l10 unit not having the ability to emit enough light.Furthermore, it is not ruled out that the bent packaging could still cause the product to degrade over time as the initial fault was not noticed.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.Gtin: (b)(4).
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Event Description
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It was reported that the stent not properly illuminating.Although there was patient involvement, there was no adverse consequence.
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Search Alerts/Recalls
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