OtherNSI
PILLCAM
Received May 23, 2005 · Event occurred May 11, 2005
Report 608309 · MDR key 608309
Device
Generic name
Capsule Endoscopy Imaging System
Manufacturer
Given Imaging, Inc.Model number
M2ACatalog number
*
Lot number
*
Product problems
- Labelling, Instructions for Use or Training Problem
- Other (for use when an appropriate device code cannot be identified)
- Device Issue
Patient
56 YR
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A DATA FROM A CAPSULE ENDOSCOPY RECORDER WAS NOT DOWNLOADED UPON COMPLETION OF THE TEST. THE RECORDER WAS NOT LABELED AS NEEDING TO BE DOWNLOADED. THE FOLLOWING DAY A NEW PATIENT WAS SET UP WITH THE DATA RECORDER AND THE DATA WAS LOST ON THIS PREVIOUS PATIENT. (DATA RECORDER DOWNLOAD NOT VERIFIED BEFORE SETTING UP NEXT PATIENT.) PROCEDURE CHANGED: FIRST STEP WILL BE TO VERIFY DATA RECORDER HAS BEEN DOWNLOADED AND SAVED PRIOR TO USE. THIS EVENT HAPPENED TWICE ON THE SAME DAY