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Catalog Number NGE-022115 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).(b)(4).Pma/510(k) # - exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
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Event Description
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It was reported during a transurethral lithotripsy (tul) procedure, the physician opened the package of the ngage nitinol stone extractor and conducted a functional check prior to use.Although the handle was manipulated, the opened basket (this product is originally packed/shipped to the customer with its basket opened) could not be closed.Another ngage nitinol stone extractor from the same lot# was used instead without problems.There were no adverse effects to the patient.
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Manufacturer Narrative
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Investigation ¿ evaluation: visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed.This included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.One device was returned for investigation.A functional test determined the handle does not actuate the basket formation.A visual examination noted the support sheath and the basket sheath are detached.A review of the device history record found there were no non-conformances associated with the complaint device lot number.A complaint history search revealed this complaint is the only one associated with lot number 8661856.Per the instructions for use (ifu): caution: this device is conductive.Avoid contact with any electrified instrument.Caution: sterile if the package is unopened or undamaged.Do not use if package is broken.Important: enclose device in sheath before removing from tray/holder.Important: excessive force could damage device.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complaint device was found to have a basket that would not close due to the support tube and sheath having separated from the handle.With the sheath separated from the handle, the motion of the handle could not be transferred to the basket to close it.Devices are inspected for damage and functionality prior to packaging.The ifu contains cautions about manipulating the device to prevent damage.The likely cause for this issue was product use or handling related - product received excessive pressure.Per the quality engineering risk assessment, no further action is warranted.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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Event Description
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It was reported during a transurethral lithotripsy (tul) procedure, the physician opened the package of the ngage nitinol stone extractor and conducted a functional check prior to use.Although the handle was manipulated, the opened basket (this product is originally packed/shipped to the customer with its basket opened) could not be closed.Another ngage nitinol stone extractor from the same lot# was used instead without problems.There were no adverse effects to the patient.
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Search Alerts/Recalls
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