COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
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Catalog Number NTSE-015115 |
Device Problems
Detachment of Device or Device Component (2907); 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 09/25/2023 |
Event Type
malfunction
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Event Description
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As reported, during a retrograde intrarenal surgery (rirs) procedure, the wire(s) of a 'ncircle tipless stone extractor' stopped functioning and the basket could not open/close.The user changed to another 'ncircle tipless stone extractor' 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 due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
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Manufacturer Narrative
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D9: device available for eval: unknown.E1: customer name and address = (b)(6).E3: customer occupation = sales support associate.G4: pma/510(k) number = exempt.H3: device evaluated by mfg = other (code unspecified, describe in h10) (81) = product to be returned: unknown.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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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.Event summary: as reported, during a retrograde intrarenal surgery (rirs) procedure, the wire(s) of a 'ncircle tipless stone extractor' stopped functioning and the basket could not open/close.The user changed to another 'ncircle tipless stone extractor' 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 due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation: 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, as well as a visual inspection and functional test of the device were conducted.One ncircle tipless stone extractor was returned in open packaging.One wire of the basket formation has pulled free from cannula, the wire is attached to rest of the device.No other damage was noted.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 events associated with the reported device lot.The evidence from the complaint file, device history record, complaint history and quality control documents indicate that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.Instructions for use (ifu): the product ifu, t_ntse_ rev1 was reviewed and provides the following information to the user: precaution: do not use excessive force to manipulate this device.Damage to the device may occur.Based on the information provided, inspection of the returned device, and the results of the investigation, cook has concluded a cause for the complaint cannot be established.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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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.Correction: d9, h3 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.Correction: h6 (annex a and annex g) 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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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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