|
Catalog Number NGE-017115 |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/06/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown or unavailable.(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, the handle of an ngage nitinol stone extractor did not "work" while being tested prior to a stone removal procedure.The distal end of device was slightly detached.A photo of the device appears to show that the device would not completely close.The procedure was complete with another same device.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.
|
|
Search Alerts/Recalls
|
|
|