LED LOUPES LIGHT UNIT
Received Feb 26, 2019 · Event occurred Jan 30, 2019
Report 2523190-2019-00026 · MDR key 8372044
Device
Product problems
- Temperature Problem
- Temperature Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THERE WAS ONE LED LOUPES LIGHT UNIT RETURNED SHOWING WEAR. THIS UNIT WAS RETURNED FOR THE REASON THE CHARGER IS GETTING HOT. TESTED THE BATTERY WITH THE CHARGER OVER NIGHT, THE CHARGER WAS WARM BUT NOT HOT. THERE WAS ANOTHER COMPLAINT THAT THE BATTERY DOES NOT FIT INTO THE BATTERY PACK, THIS IS CONFIRMED. THIS TYPE OF DAMAGE IS CONSISTENT WITH THE PINS BEING SLIGHTLY BENT. THIS COMPLAINT IS CONFIRMED/DAMAGED WORN. NO MANUFACTURING, WORKMANSHIP, OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. DEVICE IDENTIFIER (B)(4).
Description of Event or Problem
A CUSTOMER REPORTED THAT ON (B)(6) 2019, THE BATTERY PACK AND CHARGER OF 15050 LED LOUPES LIGHT UNIT WAS HOT. THE PRODUCT WAS NOT IN CONTACT WITH THE PATIENT. NO PATIENT INJURY OR DEATH ALLEGED, AND THE EVENT DID NOT LEAD TO INCREASE THE SURGERY TIME. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 BY THE HOSPITAL MANAGER STATED THAT THE CHARGER THEY RECEIVED WAS NOT THE ONE PICTURED ON THE FRONT OF THE MANUAL, WHICH WAS THE ONE THEY BORROWED WHEN TESTING OUT THE LOUPES. THE CHARGER AND BATTERY DID NOT FIT WELL TOGETHER. THE CHARGER GOT HOT AS THE BATTERY WAS CHARGING, BUT PROBABLY FEELS THIS IS DUE TO THE TWO (2) PIECES NOT FITTING WELL TOGETHER.