MalfunctionHNX
SPAIDE PEDIATRIC SCLERAL DEPRESSOR
Received Dec 8, 2011 · Event occurred Nov 8, 2011
Report 2383076 · MDR key 2383076
Device
Generic name
Scleral Depressor
Manufacturer
Bausch & Lomb, Storz OphthalmicsModel number
E5112Catalog number
*
Lot number
*
Product problems
- Crack
- Scratched Material
Patient
9 WK
- Eye Injury
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
THE OPHTHALOMOLOGIST WAS PERFORMING AN EYE EXAM USING A SCLERAL DEPRESSOR ON A 9 WEEK OLD PREMIE. A SUBCONJUNCTIVAL BLEED WAS NOTED. THE TIP OF THE INSTRUMENT WAS NOTED TO HAVE A SHARP BURR. ON CLOSER INSPECTION A HAIRLINE CRACK WAS NOTED AT THE TIP OF THE INSTRUMENT.