inforMED
MalfunctionFSO

OPMI PENTERO

Received Dec 15, 2017 · Event occurred Nov 16, 2017

Report 9615010-2017-00018 · MDR key 7123844

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Model number

NA

Catalog number

000000-0480-801

Lot number

NA

Product problems

  • Device Displays Incorrect Message
  • Device Operational Issue
  • Device Displays Incorrect Message
  • Device Operational Issue

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

CZMI MADE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION REGARDING THE SURGERY AND THE PATIENT OUTCOME. A RESPONSE FROM HCP HAS NOT BEEN RECEIVED TO DATE.

Description of Event or Problem

THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT DURING A PROCEDURE THE LAMP OF THE OPMI PENTERO SYSTEM SHUT OFF AND PROMPTED AN ERROR MESSAGE OF "ERROR DEFECTIVE LAMP, 1282/-1157". A CZMI TECHNICAL SUPPORT ENGINEER (TSE) ADVISED HCP TO SWITCH TO THE BACKUP LAMP; HOWEVER, THE PROBLEM RETURNED IN A MINUTE OR TWO. THE TSE THEN ADVISED HCP TO SWITCH TO A BACK UP MICROSCOPE, IF POSSIBLE. IT IS UNKNOWN IF MICROSCOPE WAS ACTUALLY SWAPPED OUT DURING THE PROCEDURE, AS WELL AS THE OUTCOME OF THE PATIENT.