|
Catalog Number NGE-017115 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/02/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown or unavailable.E1: customer address =(b)(6) , e1: customer phone = (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.
|
|
Event Description
|
As reported, during a stone removal procedure, the wire of an ngage nitinol stone extractor detached from its sheath.The device was tested prior to use, and it successfully retrieved three stones before encountering the problem.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.
|
|
Search Alerts/Recalls
|
|
|