MalfunctionFSO

OPMI PENTERO

Received Dec 26, 2013 · Event occurred Nov 26, 2013

Report 3649574 · MDR key 3649574

Device

Generic name

Microscope, Surgical, General And Plastic Surgery

Manufacturer

Carl Zeiss Meditec, Inc.

Model number

Catalog number

Lot number

Product problems

Device Displays Incorrect Message

Patient

70 YR

No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

MICROSCOPE LIGHT TURNED OFF AND READ AN ERROR MESSAGE DURING A CRITICAL PART OF A FREE FLAP. A REPLACEMENT WAS BROUGHT TO THE OR AND WAS USED. ABOUT 25 MINUTES WAS ADDED TO THE PROCEDURE AS A RESULT OF LIGHT GOING OUT. THERE WAS NO PATIENT HARM.====================== MANUFACTURER RESPONSE FOR OPERATING MICROSCOPE, PENTERO MICROSCOPE (PER SITE REPORTER).====================== THEY ARE REPAIRING IT.