inforMED
InjuryPGD

PILLCAM

Received Aug 12, 2021 · Event occurred Jul 15, 2021

Report 9710107-2021-00372 · MDR key 12315405

Device

Generic name

Colon Capsule Imaging System

Model number

FGS-0517

Catalog number

FGS-0517

Product problems

  • Entrapment of Device
  • Entrapment of Device

Patient

Not reported

  • Unintended Radiation Exposure
  • Unintended Radiation Exposure

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 WAS ADMITTED INTO EMERGENCY WITH CAPSULE RETENTION AND WAS EXPERIENCING SYMPTOMS OF NAUSEA AND ABDOMINAL PAIN. THE RETENTION WAS IN THE SMALL BOWEL. THE SMALL BOWEL OBSTRUCTION WAS POSSIBLY COMPLICATED BY PERFORATION. THE PATIENT HAD A CT SCAN LAST MONTH WHICH WAS NORMAL BUT SHOWED BILATERAL INGUINAL HERNIAS CONTAINING BOWEL. HOWEVER IT DID NOT LOOK AS IF THE CAPSULE WAS IN THE GROIN. THE RETENTION WAS DUE TO PATIENT PATHOLOGY NOT EQUIPMENT OR CAPSULE FAILURE. THE PATIENT WAS STILL IN HOSPITAL AT THE TIME OF REPORT.