InjuryNSI
PILLCAM PATENCY CAPSULE, 5-PACK
Received Nov 17, 2016 · Event occurred Oct 18, 2016
Report 9710107-2016-01096 · MDR key 6109004
Device
Generic name
System, Imaging, Esophageal, Wireless, Capsule
Manufacturer
Given Ltd (israel)Model number
FGS-0110Catalog number
FGS-0110
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
42 YR
- Abdominal Pain
- Diarrhea
- Nausea
- Abdominal Pain
- Diarrhea
- Nausea
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
ACCORDING TO THE REPORTER, THE PATENCY CAPSULE HAS NOT DISSOLVED. THE CAPSULE WAS INGESTED ON (B)(6) 2016. ON (B)(6), ABDOMINAL XRAYS SHOWED THE CAPSULE IN THE ASCENDING COLON. ON (B)(6), ANOTHER XRAY SHOWED THAT THE CAPSULE IS STILL IN THE ASCENDING COLON. THE PATIENT HAS EXPERIENCED FREQUENT DIARRHEA AND HER USUAL NAUSEA AND ABDOMINAL PAIN. THERE IS NO EVIDENCE OF OBSTRUCTION.