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As reported, during a ureteroscopy procedure and using a ncircle tipless stone extractor, the handle broke.The device was used through a semi-rigid ureteroscope.When the handle transitioned into the yellow sleeve reinforcement, it cracked and broke.The physician had to do some maneuvering with the device but was able to complete the procedure with the complaint device.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse events were reported due to the occurrence.
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As reported, during a ureteroscopy procedure and using a ncircle tipless stone extractor, the handle broke.The device was used through a semi-rigid ureteroscope.When the handle transitioned into the yellow sleeve reinforcement, it cracked and broke.The physician had to do some maneuvering with the device but was able to complete the procedure with the complaint device.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse events were reported due to the occurrence.
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Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Corrected information: h6: component code.Event summary: as reported, during a ureteroscopy procedure and using a ncircle tipless stone extractor, the handle broke.The device was used through a semi-rigid ureteroscope.When the handle transitioned into the yellow sleeve reinforcement, it cracked and broke.The physician had to do some maneuvering with the device but was able to complete the procedure with the complaint device.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse events were reported due to the occurrence.Investigation - evaluation a document-based investigation was performed including a review of complaint history, device history record, manufacturing instructions, quality control data, and the instructions for use (ifu).The complaint device was not returned.A photo of the device was provided by the user.The photo clearly showed the yellow support sheath had separated near the handle.A review of the device history record found no non-conformances related to the reported failure mode.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 related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precaution: the device is conductive.Avoid contact with any electrified instrument.Precaution: enclose the device in the sheath before removing from the tray/holder.Precaution: do not use excessive force to manipulate this device.Damage to the device may occur.The cause for the damage was unknown.Excessive force may have been inadvertently applied to the device, however no information was known regarding device handling, therefore the cause of the issue could not be conclusively determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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