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Catalog Number NGE-017115 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/06/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E1: address: (b)(6).G4 : 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.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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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As reported, prior to use for an unknown procedure, the user opened the packaging of an ngage nitinol stone extractor and found the basket could not be used.The device did not make patient contact.Another same type device was used to complete the procedure.It was reported, that the patient did not require any additional procedures or experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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Investigation ¿ evaluation: as reported, prior to use for an unknown procedure, the user opened the packaging of an ngage nitinol stone extractor and found the basket could not be used.The device did not make patient contact.Another same type device was used to complete the procedure.It was reported that the patient did not require any additional procedures or experience any adverse effects due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control, manufacturing instructions (mi), and instructions for use (ifu), as well as a visual inspection and functional test of the returned device, and interviewing personnel were conducted during the investigation.One device was returned to cook for investigation in an open package with label.A visual exam notes basket formation has separated from the basket sheath.The shrink tube and glue that secures the basket to the basket sheath had not held the two components together.A document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot revealed no recorded non-conformances relevant to the failure mode.A review of complaints with the same lot number shows 3 other complaints.Two out of the three recorded complaints are related to the current failure mode.The information provided upon review of complaint file, device history record, complaint history and quality control documents do not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming.Cook also reviewed product labeling.The product ifu, t_shef_rev1; the ifu did not provide any information related to the reported issue.Based on the information provided, inspection of the returned device, and the results of the investigation, a cause had not been determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, 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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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Search Alerts/Recalls
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