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Model Number G48294 |
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 02/20/2024 |
Event Type
malfunction
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Event Description
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As reported, prior to an unspecified procedure, two ngage nitinol stone extractor baskets could not be opened.A third device of the same type was used to complete the procedure.Upon preliminary inspection of the returned devices, no damage to the device was noticed; but, the baskets would not open/close with the handle.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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G4: pma/510(k) number = exempt.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d4: model # = gpn # investigation - evaluation as reported, prior to an unspecified procedure, two ngage nitinol stone extractor baskets could not be opened.A third device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Interview of personnel was also conducted.Functional tests and visual inspection of the returned complaint devices were also conducted.Two devices were returned for investigation in an open package with label.Upon inspection no damage to the device was noticed.Handle was actuated, and the baskets would not open/close.Cook has concluded that the device was manufactured to specification.Additionally, 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 device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The ifu supplied with the device did not provide any information related to the reported issue.Based upon the available information, inspection of the returned devices and results of the investigation, cook has concluded that the cause for the complaint could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.Per the quality engineering 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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