|
Model Number FGS-0313 |
Device Problem
Loss of or Failure to Bond (1068)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
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 and the delivery system.
|
|
Manufacturer Narrative
|
Evaluation summary: this report is based on information provided by medtronic investigation personnel.The bravo device was received for evaluation.The returned sample met specification as received by medtronic.The customer reported they had a capsule which failed to attach.The reported condition was not confirmed.The investigation found the device to function normally and within specifications.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 and the delivery system and capsule will be returned for investigation.
|
|
Search Alerts/Recalls
|
|
|