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Catalog Number NGE-022115-MB |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/13/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Investigation - evaluation: a review of the device history record and quality control of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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Event Description
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It was reported by the user facility that while using ncircle tipless stone extractors, the devices cannot close easily after being opened.It was noted that two failures came from the week prior and three failures from the week of this report.The number of patients affected by these occurrences is unknown however; the reporter did indicate that none of the patients experienced any adverse effects due to these incidents.No further information was provided.This medwatch is for the two baskets in question; reference mfr 1820334-2017-00428 to capture the remaining three baskets reported.
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Search Alerts/Recalls
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