PILLCAM
Received Sep 27, 2018 · Event occurred May 7, 2018
Report 9710107-2018-00962 · MDR key 7916680
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Imaging Ltd., YoqneamModel number
FGS-0109Catalog number
FGS-0109
Lot number
36752
Product problems
- Material Fragmentation
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, THERE WAS AN UNDISSOLVED PATENCY CAPSULE FOUND IN THE PATIENT¿S FECES WITH BLOOD FROM A RELATIVELY SMALL BOWEL STENOSIS. THE CAPSULE ONLY DISSOLVED A LITTLE AT BOTH ENDS, WHICH SHOULD HAVE BEEN DISSOLVED AFTER 36 HOURS. THE PATIENT HAD ILEUS SYMPTOMS, WHICH LED TO HOSPITALIZATION AND THEN THE PATIENT DID NOT HAVE LATER COMPLICATIONS AFTER THE HOSPITALIZATION. THERE WAS NO REPORTED PATIENT OUTCOME.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ACCORDING TO THE REPORTER, THERE WAS AN UNDISSOLVED PATENCY CAPSULE FOUND IN THE PATIENT¿S FECES WITH BLOOD FROM A RELATIVE SMALL BOWEL STENOSIS. THE CAPSULE ONLY DISSOLVED A LITTLE IN BOTH ENDS, WHICH SHOULD HAVE BEEN DISSOLVED AFTER 36 HOURS. THE CAPSULE WAS USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE AND SUBSEQUENTLY MEDICAL INTERVENTION WAS NECESSARY, RESULTING IN HOSPITALIZATION OF THE PATIENT AFTER PASSING OF THE CAPSULE. THE PATIENT HAD ILEUS SYMPTOMS WHICH LED TO HOSPITALIZATION AND THEN THE PATIENT DID NOT HAVE LATER COMPLICATIONS AFTER THE HOSPITALIZATION. THERE WAS NO REPORTED PATIENT OUTCOME.