As reported, during a stone removal procedure, the handle of the ncircle tipless stone extractor detached from blue sheath and the basket could not be opened.Attempted use of this device was after a cystoscope pneumatic lithotripsy to remove bladder stones approximately 24mmx26mm in size.Another same-like device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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Blank fields on this form indicate the information is unknown or unavailable.E1: customer name and address = postal code: (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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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: g2 investigation ¿ evaluation as reported, during a stone removal procedure, the handle of the ncircle tipless stone extractor detached from blue sheath, and the basket could not be opened.Attempted use of this device was after a cystoscope pneumatic lithotripsy to remove bladder stones approximately 24mmx26mm in size.Another same-like device was used to complete the procedure.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.A device failure analysis was conducted on the returned device.The returned device was nonfunctional due to damage.A visual examination found the blue basket sheath was severely damaged at the handle.The basket sheath was torn and separated.The red cap of the protective shipping hoop was attached to the handle.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the dhr for the reported lot and recorded no relevant non-conformances.A database search revealed no other related complaints had been reported from the complaint 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.Cook also reviewed product labeling.The product ifu, t _ ntse_ 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, the specific cause of the damage could not be established.It is possible that having the red cap still attached to the handle during use caused or contributed to the damage.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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