inforMED
InjuryNSI

PILLCAM

Received Jun 20, 2018 · Event occurred May 30, 2018

Report 9710107-2018-00779 · MDR key 7620093

Device

Generic name

System, Imaging, Esophageal, Wireless, Capsule

Model number

FGS-0109

Catalog number

FGS-0109

Product problems

  • Material Fragmentation
  • Material Fragmentation

Patient

60 YR

  • Abdominal Pain
  • Radiation Exposure, Unintended
  • Abdominal Pain
  • Radiation Exposure, Unintended

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, THE PATIENT EXPERIENCED PROJECTILE VOMITING OF SLIMY MATERIAL AND EPIGASTRIUM PAIN. TECHNICAL SUPPORT FORWARDED THE COMPLAINT TO THE MEDICAL STAFF. THE CUSTOMER HAD A CONVERSATION WITH THE MEDICAL STAFF THROUGH EMAIL AND STATED THAT AN ABDOMINAL X-RAY WAS PERFORMED AND OBSERVED TWO RODS. ON THE RECENT KIDNEY, URETER AND BLADDER ULTRASOUND, THE RADIOLOGIST STATED THAT THE CAPSULE APPEARED TO BE SEPARATED AND SOME OF IT WAS LODGED IN THE GASTROESOPHAGEAL JUNCTION WHILE OTHER BITS OF IT WERE IN THE COLON. THE PATIENT WAS FEELING BETTER.