Model Number N/A |
Device Problem
Material Separation (1562)
|
Patient Problem
No Code Available (3191)
|
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).The event is currently under investigation.
|
|
Event Description
|
The tether broke off before it was time to remove the stent.The patient had to come in to the physician's office for stent removal via scope and forceps.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
|
|
Manufacturer Narrative
|
(b)(4).Event evaluation - a review of complaint history, instructions for use (ifu), quality control and trends was conducted during the investigation.No product or imaging were returned to assist with this investigation.The ifu details: "the stent may be removed easily by gentle withdrawal traction using endoscopic forceps." there is no evidence to suggest that the device was not manufactured to specification.Based on the information provided, the root cause is unable to be determined or reported at this time.We will continue to monitor for similar complaints.The appropriate internal personnel have been notified.
|
|
Event Description
|
The tether broke off before it was time to remove the stent.The patient had to come in to the physician's office for stent removal via scope and forceps.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
|
|
Search Alerts/Recalls
|