MalfunctionFFX

SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL)

Received Jan 2, 2026

Report MW5181570 · MDR key 23943746

Device

Generic name

System, Gastrointestinal Motility (electrical)

Manufacturer

Diversatek Healthcare, Inc.

Patient

NA · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL INTERVENTION TO REPLACE THIS NON-(B)(6) DEVICE FOR UNSPECIFIED REASONS. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).