|
Model Number FGS-0313 |
Device Problem
Loss of or Failure to Bond (1068)
|
Patient Problem
No Information (3190)
|
Event Date 05/31/2019 |
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.There was no harm to the patient, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule.A scope was used to check the placement of the capsule.
|
|
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.There was no harm to the patient, no intervention was required, and a repeat procedure was performed.There was nothing unusual about the patient or the procedure and an endoscopy had been performed prior to the procedure and showed the esophagus to be normal.No lubrication was used to facilitate placement of the capsule.A scope was used to check the placement of the capsule.The patient endured placement of two capsules, neither of which attached, and had to return for a repeat endoscopy procedure and capsule placement.
|
|
Search Alerts/Recalls
|
|
|