inforMED
MalfunctionHBI

VITAL VUE

Received Sep 6, 2018 · Event occurred Jul 25, 2018

Report 3004593495-2018-00840 · MDR key 7852838

Device

Generic name

Illuminator, Fiberoptic, Surgical Field

Manufacturer

Plexus Corp

Model number

8886828426

Catalog number

8886828426

Lot number

U0812375

Product problems

  • Sparking
  • Sparking

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC UROLOGY, THE DISPOSABLE DID NOT WORK PROPERLY SO THE CUSTOMER REQUESTED TO CHECK THE BODY PART. A SPARK CAME OUT FROM THE TIP OF THE PRODUCT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.