inforMED
MalfunctionFDE

CARDINAL HEALTH

Received Apr 23, 2026 · Event occurred Apr 1, 2026

Report 24965494 · MDR key 24965494

Device

Generic name

Laparoscopy Kit

Model number

SBAHDLPAGA

Catalog number

SBAHDLPAGA

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING THE SURGICAL PROCEDURE, WHILE BEING REMOVED THROUGH THE LAPAROSCOPIC PORT, THE RAYTEC SPONGE SHREDDED. THE FIELD WAS VISUALLY INSPECTED AND NO FRAGMENTS WERE FOUND TO BE RETAINED IN THE PATIENT.