Blank fields on this form indicate the information is unknown or unavailable.E1: street address: (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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As reported, during a flexible transurethral lithotomy (tul) in the urinary duct, an ngage nitinol stone extractor was used to remove stones after they were broken down by the laser.On the second pass at collecting a stone, the device could not be inserted into the scope due the basket could not be closed completely.The laser was not used at the same time as the basket.The device was tested prior to use and functioned properly.Another device of the same type, with an unknown lot, was used 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 and did not experience any adverse effects due to this occurrence.
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Corrected information: d4.H6: medical device problem code (annex a), component code (annex g).Investigation evaluation: description of event: as reported, during a flexible transurethral lithotomy (tul) in the urinary duct, an ngage nitinol stone extractor was used to remove stones after they were broken down by the laser.On the second pass at collecting a stone, the device could not be inserted into the scope due the basket could not be closed completely.The laser was not used at the same time as the basket.The device was tested prior to use and functioned properly.Another device of the same type, with an unknown lot, was used 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 and did not experience any adverse effects due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control (qc) procedures, as well as interview personnel, a visual inspection, and functional test of the returned device, were conducted during the investigation.One ngage nitinol stone extractor was returned without package or label.Handle would actuate the basket.The basket functions normally.There was some damage to the basket wire shrink tubing.Additionally, 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 device history record (dhr) found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that that the device was manufactured to specification and there is no evidence that nonconforming product exists in house or in the field.A review of the ifu provides the following information: suggested handling instructions for extractors and forceps: important: excessive force could damage device.The returned device was found to have a basket that did open and close when the handle was functioned.There was some minor damage to the basket noted.The distal ends of the basket wire shrink tubing was slightly split.The damage did not affect the ability of the basket to close when tested in the laboratory, but it is possible when the device was used in the clinical setting, the ability of the basket to close properly was affected.The cause for the damage could not be established.The appropriate personnel have been notified and cook will continue to monitor for similar events.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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