inforMED
MalfunctionLRP

BIOSEAL

Received Jun 5, 2025 · Event occurred May 8, 2025

Report 22148787 · MDR key 22148787

Device

Generic name

Tray, Surgical

Manufacturer

Bioseal

Catalog number

7320/50

Lot number

1644

Product problems

  • Material Separation
  • Defective Device

Patient

64 YR · Female

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

LOT #1644. LITWIN RIPPED IN TWO WHILE IN TROCAR. TWO PIECES RECOVERED. SURVEYED BODY NO LITWIN NOTED. TROCAR CHANGED.