L300 SURGICAL ILLUMINATOR
Received Aug 28, 2012
Report 1222895-2012-00025 · MDR key 2719410
Device
Generic name
Cogent 270 Surgical Illuminator
Manufacturer
Integra Burlington, Ma Inc.Catalog number
90123
Product problems
- Break
- Burst Container or Vessel
- Smoking
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
CUSTOMER INITIALLY REPORTS THE UNIT WAS INVOLVED IN AN INCIDENT. THE LAMP LITERALLY EXPLODED TAKING OUT THE REFLECTORS. SOME PARTS WERE REPLACED BY BIOMEDICAL DEPARTMENT IN AN ATTEMPT TO REPAIR THE UNIT. ON (B)(4) 2012, BIOMEDICAL DEPT AND SURGICAL EQUIPMENT TECH REPORT NO REAL "EXPLOSION", THE DEVICE SMOKED AND THE DEVICE LAMP AND BOTH REFLECTORS WERE SIGNIFICANTLY DAMAGED. THIS OCCURRED DURING "BACK" SURGERY AND THERE WAS NO HARM TO PT OR STAFF. DEVICE WAS QUICKLY REPLACED AND THERE WAS NO REAL DOWNTIME.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.