As reported, during the beginning of a flexible ureteroscopic lithotomy procedure, the basket of the circle tipless stone extractor would not open to gather a stone located in the kidney.The user retracted the basket from patient and found out the basket wire broken (the provided pictures and video shows the basket wire was detached from the cannula).The procedure was completed with another circle tipless stone extractor.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
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Blank fields on this form indicate the information is unknown or unavailable.E1- 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, h6 (annex a and annex g).Investigation ¿ evaluation: it was reported that the basket of a ncircle tipless stone extractor would not open to gather a stone located in the kidney during a flexible ureteroscopic lithotomy procedure.The user retracted the basket from the patient and discovered that a basket wire had "broken".The customer provided pictures and video show the basket wire was detached from the cannula.Another same device was used to complete the procedure.The patient experienced no harm as a result of the issue.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions, and quality control procedures, as well as a functional test and visual inspection of the returned device and customer provided photographs and video, were conducted during the investigation.A device failure analysis was conducted on the returned device.Visual examination notes that the returned device was found to have had 1 of the 4 basket wires pulled free from the basket cannula that secures the proximal end of the basket wires in place.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 device history record (dhr) which records no relevant non-conformances related to this incident.A database search for complaints on the reported lot found no additional complaints reported from the field.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 cause for the wire separation could not 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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