COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTSE-015115 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/02/2017 |
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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The user facility reported during a transurethral lithotripsy procedure, prior to insertion into the patient's body, the physician conducted a functional test of the ncircle tipless stone extractor.The physician found the basket would not open or close when the handle was manipulated.See case with manufacturer report number 1820334-2017-01477.A second device was used but the basket would not open or close either.This report is for the second device.A third device was used and the procedure was completed without any problems.There were no adverse effects.It was stated that the second device would not be returned.
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Manufacturer Narrative
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Investigation summary: a review of the quality control and specifications was completed during this investigation.The complaint device was not returned therefore, device failure analysis and physical examination of the device used in this case could not be performed.Current controls are in place in manufacturing to assure device functionality prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.There is no indication that a design or process related failure mode contributed to this event.Based on the available information, exact root cause can not be determined at this time.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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