inforMED
GDB

*

Received Nov 18, 2013 · Event occurred Nov 18, 2013

Report 3485604 · MDR key 3485604

Device

Generic name

Endoscope

Manufacturer

*

Model number

PCF-160AL

Catalog number

*

Lot number

*

Product problems

  • Material Separation
  • Device Operates Differently Than Expected

Patient

*

  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

AFTER PROCEDURE, SCOPE FAILED LEAK TEST AND SEPARATED AT SEPARATING LOCK. SCOPE HAD JUST RETURNED FROM SERVICE REPAIR.