Model Number 173016 |
Device Problems
Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/31/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during laparoscopic nissen procedure, the device¿s needle popped out of jaws while being used in wrap.Surgeon was midway through suturing and completed tie with graspers.The needle fell into the patient cavity and was retrieved by graspers.There was no injury caused to the patient and no medical intervention was required.
|
|
Manufacturer Narrative
|
Evaluation summary post market vigilance (pmv) led an evaluation of one device.Visual functional indicated no abnormalities.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during laparoscopic nissen procedure, the device¿s needle popped out of jaws while being used in wrap.Surgeon was midway through suturing and completed tie with graspers.The needle fell into the patient cavity and was retrieved by graspers.New device was used successfully with two subsequent loads without issue.There was no injury caused to the patient and no medical intervention was required.
|
|
Search Alerts/Recalls
|