inforMED
MalfunctionNSI

PILLCAM

Received Aug 29, 2018 · Event occurred Jul 31, 2018

Report 7826086 · MDR key 7826086

Device

Generic name

System, Imaging, Esophageal, Wireless, Capsule

Model number

FGS-0155

Catalog number

FGS-0155

Lot number

40041S

Product problems

  • Data Problem

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PATIENT WAS SCHEDULED FOR AN M2A STUDY BUT WE WERE UNABLE TO CAPTURE DATA/READ STUDY. PATIENT WILL NEED TO REPEAT STUDY AT DIFFERENT TIME.