inforMED
MalfunctionHAW

DISPOSABLE REFLECTIVE MARKER SPHERES

Received Nov 5, 2013 · Event occurred Sep 12, 2013

Report 3002743211-2013-00002 · MDR key 3451481

Device

Generic name

Haw, Olo

Model number

41773

Lot number

A4011013001

Product problems

  • Degraded
  • Device Slipped
  • Scratched Material

Patient

Not reported

  • No Information

Narrative

Additional Manufacturer Narrative

NONE.

Description of Event or Problem

PRODUCT APPEARED TO BE "SCUFFED." ALSO ISSUES WITH SPHERES STRIPPING AND NOT STAYING ON THEIR POSTS. EITHER ISSUE MAY AFFECT THE REGISTRATION PROCESS OR SPHERE MARKER TRACKING ABILITY. IN MOST CASES, SPHERES ARE SWITCHED OUT.