COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Model Number N/A |
Device Problems
Device Operates Differently Than Expected (2913); 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 04/13/2017 |
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 customer reported that the ngage nitinol stone extractor basket malfunctioned towards the end of an intended right ureteroscopy with laser lithotripsy and stone extraction procedure, when the physician was attempting to remove another stone from the patient's body.The malfunction was described as the basket would not deploy out of the sheath.The customer used another ngage nitinol stone extractor basket to retrieve the remaining stones and successfully completed the procedure.No unintended section of the device remained inside the patient¿s body.The patient did not require an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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The following methods were performed during the investigation: dimensional verification, functional test, review of complaint history, review of device history record, review of quality control, and visual inspection of the device.The document based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of device history record and quality documentation shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.A visual examination of the returned device noted a kink in the basket sheath 83 cm from the distal tip and the support sheath is partially severed 1 mm from the mlla tubing.The back of the support sheath shows stress marks but it did not severe.A functional test was performed and the unidex handle (udh) would not actuate the basket formation.Based on the provided information a definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
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