Catalog Number NGE-022115-MB |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/30/2023 |
Event Type
malfunction
|
Event Description
|
As reported, three ngage nitinol stone extractors were unable to open properly.There have been no adverse event reported due to this occurrence.Additional information regarding the event has been requested.
|
|
Manufacturer Narrative
|
E1 - (b)(6).E3 - occupation: administration tech.G4 : pma/510(k)# = 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.
|
|
Manufacturer Narrative
|
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
|
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
|
|
Event Description
|
Additional information was received on 16jan2024 clarifying that this event involved three devices during one procedure.The procedure was completed with a functioning extractor.As reported, the patient did not experience any adverse effects or require an additional procedure.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|