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Catalog Number NGE-017115 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/31/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient code: no consequences or impact to patient.Device code: material split, cut or torn ((b)(4)) is not labeled.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, the user selected the ngage nitinol stone extractor for transurethral urinary stone extraction.When he took the device out from the tray prior to patient contact, he found the red support sheath was severed already.The device was not used.He replaced it with another device to complete the procedure.Additional information received on (b)(6) 2018.The device is in a closed position.The actuator button works, but the basket does not open or close.
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Manufacturer Narrative
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H6: evaluation conclusion codes: cause not established (4315).Investigation evaluation: a visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed which 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 tight.The polyethylene terephthalate tubing (pett) measures 3.7 cm in length.A functional test determined the handle does not function the basket formation.A visual examination noted the support sheath is severed 5 mm from the nose of the mlla.The remaining support sheath measures 3.7 cm and is still adhered to basket sheath.The support sheath at the mlla is no longer attached to basket sheath.There is glue noted on the basket sheath.The points of separation were found to match up.The basket sheath was found to be free of kinks.A review of the device history record found there were no non-conformances associated with the complaint device lot number.A review of complaint history records revealed this complaint is the only one associated with lot number 8470477.The instructions for use (ifu) provides the following: 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.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 open due to sheath damage.The support sheath was broken, preventing the motion of the handle from being transferred to the basket sheath.Devices are inspected for damage and functionality prior to packaging.The observed damage likely occurred during handling of the device.The ifu contains cautions about manipulating the device to prevent damage.Since no information related to the product handling is available: the definitive cause for the sheath damage was not established.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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Event Description
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There has been no new information received since the last report was submitted.
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Search Alerts/Recalls
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