inforMED
InjuryFSO

OPMI PENTERO

Received Jul 16, 2019 · Event occurred Jun 17, 2019

Report 9615010-2019-00005 · MDR key 8796065

Device

Generic name

Microscope, Surgical, General & Plastic Surgery

Model number

N/A

Catalog number

302582-9901-000

Lot number

N/A

Product problems

  • Misfocusing
  • Mechanical Jam
  • Physical Resistance/Sticking
  • Misfocusing
  • Mechanical Jam
  • Physical Resistance/Sticking

Patient

Not reported

  • No Code Available
  • No Code Available

Narrative

Additional Manufacturer Narrative

IN CASE OF A HARDWARE FAILURE DURING A SURGERY, THE MICROSCOPE HAS A "LIGHT ONLY" FEATURE AVAILABLE. IN THE "LIGHT ONLY" MODE, THE USER IS ABLE TO OPERATE THE FOCUS FUNCTION MANUALLY WITHOUT ANY ELECTRONIC CONTROL FUNCTION. THE USER MANUAL DESCRIBES HOW TO SWITCH TO THE "LIGHT ONLY" MODE. IN THIS CASE A CZMI TECHNICAL SUPPORT ENGINEER SUGGESTED THE HCP TO SWITCH TO THE "LIGHT ONLY" MODE. HOWEVER, THE DOCTOR DECIDED TO ABORT THE SURGERY AND RESCHEDULE IT FOR A LATER DATE.

Description of Event or Problem

A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT DURING A MINIMAL INVASIVE MICRO DISCECTOMY PROCEDURE, THE DOCTOR COULD NOT MOVE THE MICROSCOPE'S FOCUS FUNCTION VIA THE HANDGRIP. THE FOCUS WAS STUCK IN THE MAXIMUM POSITION. THE HCP REPORTED THAT THE SURGERY WAS ABORTED AND THE PATIENT WAS BROUGHT BACK AT A LATER DATE TO COMPLETE THE PROCEDURE. THE HCP CONFIRMED THAT THERE WAS NO INJURY TO THE PATIENT DUE TO THE MICROSCOPE ISSUE.

Additional Manufacturer Narrative

FIELD G7: UPDATED FROM "INITIAL" TO "FOLLOW-UP #: 1" FIELD H2: ENTERED "DEVICE EVALUATION" FIELD H10: UPDATED MANUFACTURER NARRATIVE AND ADDED DESCRIPTIONS OF CHANGES.