COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTSE-022115-UDH |
Device Problem
Device Operational Issue (2914)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Pma/510k # ¿ 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, as they were prepping for a ureteroscopy, when they tried to open the basket of the ncircle tipless stone extractor , it would not deploy, the basket portion would not come out of the sheath.The issue was found prior to patient contact.A new ncircle tipless stone extractor was opened and used to complete the procedure.No patient involvement.
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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, manufacturing instructions, and quality control data.One device was returned for investigation.The device was returned with the handle in the open position and the basket formation in the closed position.The collet knob is tight and secure.The male luer lock adapter (mlla) is loose.The polyethylene terephthalate tubing (pett) measures 2.5 cm in length.A visual examination noted the support sheath is severed 5 mm from the mlla with 1 cm of coil exposed.The exposed coil is bent.The remaining support sheath and basket sheath are still adhered.A functional test noted the handle does not actuate the basket formation.There were kinks found in the basket sheath at 2 cm from the distal tip of the basket sheath and again at 49 cm and 93.3 cm from the distal tip.When the investigator held the two segments of the support sheath tightly together the handle would actuate the basket formation.A review of the device history record found there were no non-conformances related to the reported failure mode.A complaint history search revealed this complaint is the only one associated with lot number 8605426.Per the instructions for use (ifu) precaution section: enclose the device in the sheath before removing from the tray/holder.Do not use excessive force to manipulate this device.Damage to the device may occur.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 function due to sheath damage.The sheath was found to be kinked in multiple places and separated near the handle.The devices are inspected for functionality and damage prior to packaging and packaged with the basket open.The condition of the returned device makes it likely that it was damaged when removing it from the package, or during subsequent handling.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, as they were prepping for a ureteroscopy, when they tried to open the basket of the ncircle tipless stone extractor , it would not deploy, the basket portion would not come out of the sheath.The issue was found prior to patient contact.A new ncircle tipless stone extractor was opened and used to complete the procedure.No patient involvement.
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Search Alerts/Recalls
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