|
Model Number M0063901050 |
Device Problems
Difficult to Open or Close (2921); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/08/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that a zero tip basket was used in the urinary tract during a ureteroscopy (urs) procedure performed on (b)(6) 2022.During the procedure, one of the wires of the basket was folded on itself and would not close properly.Additionally, the sheath was torn at the distal end.The procedure was completed with another zero tip basket.There were no patient complications as a result of this event.
|
|
Manufacturer Narrative
|
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
|
|
Search Alerts/Recalls
|
|
|