|
Catalog Number NGE-017115 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown or unavailable.G4: pma/510(k) number = exempt.H3: device evaluated by mfg = other (81) -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.
|
|
Event Description
|
As reported, prior to a flexible ureteroscopic procedure, an ngage nitinol stone extractor's basket wire detached and the basket could not be opened.Another device of the same type was used to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention and did not experience any adverse effects due to this occurrence.
|
|
Search Alerts/Recalls
|
|
|