COOK INC NCOMPASS NITINOL TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NCT4-017115 |
Device Problems
Device Inoperable (1663); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
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Event Description
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It was reported via the area representative that the ncompass nitinol tipless stone extractor did not function at all when removed from the package.As reported, the patient was not affected.There were no adverse effects to the patient due to this device issue.Additional patient and event details have been requested but not received at the time of this report filing.
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Manufacturer Narrative
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Investigation ¿ evaluation: the ncompass nitinol tipless stone extractor was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of quality control data and device specifications was performed.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record could not be reviewed as the lot number of the device was not available.In addition, a complaint history review was not able to be performed for the complaint device lot.Based on the provided information and the investigation evaluation a root cause for the reported issue could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.
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