Catalog Number 0250070443 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Burn(s) (1757)
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Event Date 10/30/2018 |
Event Type
Injury
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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 patient was burned.The procedure was completed successfully.
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Event Description
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It was reported that the patient was burned.The procedure was completed successfully.
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Manufacturer Narrative
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The tracking number provided showed that the package was signed for at stryker endoscopy, but the product was not received by the returns department.Therefore, it can not be confirmed that the device was received.In the event that the product is located, the complaint will be reopened and the investigation will be updated with the new results.The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: additional burn occurred to patient liver where bleeding was occurring.Probable root cause: material/design error.Manufacturing/assembly error.Severe shipping conditions.User error.The failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
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Search Alerts/Recalls
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