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Catalog Number NGE-017115-MB |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Blank fields on this form indicate the information is unknown or unavailable.E1: customer street = (b)(6).E1: customer line 2 = (b)(6).E1: customer postal code = 710000 e1: customer phone = (b)(6).E3: customer occupation = agent g4: pma/510(k) number = exempt h3: 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.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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As reported, the user checked the ngage nitinol stone extractor before ureteroscopic holmium laser lithotripsy for stone removal and confirmed it was intact.The device was advanced through the flexible ureteroscopes' working channel and a stone was captured.The user noticed that one of the basket wires broke when viewed under the endoscope.The stone was released and the device was removed from the patient and the broken wire was confirmed.No portion of the device was left in the patient.Subsequently, the user switched to another same device to complete the procedure.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.
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Search Alerts/Recalls
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