COOK INC NTRAP STONE ENTRAPMENT AND EXTRACTION DEVICE; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTP-028145 |
Device Problems
Difficult to Open or Close (2921); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
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: customer phone= (b)(6).G4: pma/510(k) number = 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, during stone extraction, the user noticed that the basket of ntrap stone entrapment and extraction device could not closed to capture the stone.Another same device was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.Additional information has been requested regarding the event.At the time of this report, no further information has been provided.
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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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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: h6 (annex a and annex g) investigation ¿ evaluation as reported, during stone extraction, the user noticed that the basket of ntrap stone entrapment and extraction device could not closed to capture the stone.The device was unable to extract any stones during the procedure prior to the issue.Another same device was used to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.A document-based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi) and quality control procedures.Additionally, a visual inspection and functional test of the device were conducted.One ntrap stone entrapment and extraction device was returned to cook for evaluation.The handle of the device was not returned.A visual exam notes kink in basket sheath 1.2 cm from distal tip, the basket cannot be manually actuated.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 database search did not identify any other complaints associated with the reported device lot.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did 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 were nonconforming.The product ifu t _ ntp_ rev1 was reviewed and 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, the cause for the kink could not be 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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Additional information received 11mar2024: the device was unable to extract any stones during the procedure prior to the issue.
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.Device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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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Search Alerts/Recalls
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