Catalog Number CS-15192-VFI |
Device Problem
Material Fragmentation (1261)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/04/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
The complaint is reported as: during use the tip of the dilator was noted to no longer be attached to the dilator.The tip was removed from the patient.No patient injury or complication reported.The patient's condition is reported as fine.
|
|
Event Description
|
The complaint is reported as: during use the tip of the dilator was noted to no longer be attached to the dilator.The tip was removed from the patient.No patient injury or complication reported.The patient's condition is reported as fine.
|
|
Manufacturer Narrative
|
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
|
|
Search Alerts/Recalls
|