inforMED
MalfunctionFSR

INTEGRA®

Received Jan 29, 2020 · Event occurred Jan 19, 2020

Report 9641375 · MDR key 9641375

Device

Generic name

Light, Headband, Surgical

Model number

90500

Catalog number

90500

Product problems

  • Smoking
  • Improper or Incorrect Procedure or Method
  • Sparking

Patient

22265 DA

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

Narrative

Description of Event or Problem

AN OPERATING ROOM PATIENT CARE TECHNICIAN WAS SETTING UP AN OPERATING ROOM FOR A SURGERY THAT REQUIRED USE OF A HEADLIGHT. THE INTEGRA HEADLIGHT IS USED ALONG WITH A BATTERY PACK THAT CLIPS TO THE SURGEON'S WAIST. THE PATIENT CARE TECHNICIAN CORRECTLY IDENTIFIED THE HEADLIGHT AND GRABBED A CORD HE BELIEVED TO BE THE CONNECTOR BETWEEN THE HEADLIGHT AND BATTERY PACK AS IT LOOKED THE SAME. HE BROUGHT THE TWO COMPONENTS TOGETHER AND STATES THERE WAS A SPARK, SMOKE, AND HE DROPPED THE TWO. THE CORD IN FACT BELONGED TO A WALL UNIT BATTERY CHARGER FOR ANOTHER PIECE OF EQUIPMENT, THE SPIDER2.