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Catalog Number NGE-017115 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/28/2022 |
Event Type
malfunction
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Event Description
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As reported, upon opening the packaging of a ngage nitinol stone extractor, the basket wires were intertwined.The procedure was completed with another new device.There have been no adverse effects reported.
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Manufacturer Narrative
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(b)(6).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.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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No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
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Manufacturer Narrative
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Additional information: d9, 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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Event summary: as reported, upon opening the packaging of a ngage nitinol stone extractor, the basket wires were intertwined.The procedure was completed with another new device.There have been no adverse effects reported.Investigation - evaluation: reviews of the complaint history, device history record, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One device was returned for investigation in an empty packaging box without pouches or product protectors.The handle was able to actuate the basket.The basket was deformed.A document-based investigation evaluation was performed.No related non-conformances were recorded.Two other complaints have been received for this product lot, reported under manufacturer report #¿s 1820334-2022-01207 and 1820334-2022-01440.The former complaint was determined to have a different cause than the subject of this report and is thus not related.There is not enough information presently available to determine that the latter complaint is related to the subject of this report.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.Based on the available information, cook has concluded that a cause for this issue could not be determined.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.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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