PILLCAM
Received Sep 7, 2018 · Event occurred Aug 22, 2018
Report 7854718 · MDR key 7854718
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging, Inc.Model number
FGS-0155Catalog number
FGS-0155
Lot number
40764S
Product problems
- Failure to Transmit Record
- Inaccurate Synchronization
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A PILLCAM CAPSULE ENDOSCOPY WAS PLANNED. THE FIRST PILLCAM WE USED HAD DIFFICULTY SYNCING WITH THE CAPSULE DATA COLLECTING DEVICE, SO A SECOND PILLCAM WAS THEN OBTAINED. THIS SECOND PILLCAM SYNCED WITH THE DEVICE, AND AN UPPER ENDOSCOPY WAS DONE TO PLACE THE PILLCAM. THE NEXT DAY, AFTER THE CAPSULE DATA WAS REVIEWED, IT WAS DISCOVERED THAT THE DATA COLLECTION WAS INCOMPLETE. THERE WERE LARGE SECTIONS WHERE RECORDING APPEARS TO BE MISSING STARTING AT ABOUT 2 HR AND 45 MINS INTO THE STUDY. THEN THE RECORDING RESUMES FOR ABOUT 3 MINS AT 3 HR 12 MINS AND THEN STOPS RECORDING AGAIN AT 3 HR 15 MINS. THE CAPSULE STOPS RECORDING ALTOGETHER AT ABOUT 3 HR 45 MINS.