COOK INC NCIRCLE TIPLESS STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL
|
Back to Search Results |
|
Model Number N/A |
Device Problem
Difficult to Open or Close (2921)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/12/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
Blank fields on this form indicate the information is unknown or unavailable.E3 occupation: manager perioperative services.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
|
It was reported, an ncircle tipless stone extractor was successfully tested prior to use, but upon insertion through the scope, the basket worked with their first attempt, but would not open after that.There was no damage to the device noted.Another same type device was used to complete the procedure.No adverse effects were noted but the patient was exposed to extended anesthesia time due to the device malfunction.
|
|
Search Alerts/Recalls
|
|
|