|
Model Number FGS-0636 |
Device Problem
Positioning Failure (1158)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/07/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, they had a capsule which failed to attach to the patient¿s esophagus and still attached to the delivery system upon removal.They placed another capsule on the same procedure and attached successfully.There was no patient and user harm, and no intervention was required.No lubrication was used to facilitate the placement of the capsule.
|
|
Search Alerts/Recalls
|
|
|