OPMI PENTERO 900
Received Sep 17, 2012 · Event occurred Sep 11, 2012
Report 2753082 · MDR key 2753082
Device
Generic name
Microscope, Surgical, General And Plastic Surgery
Manufacturer
Carl Zeiss Microscopy, LlcModel number
PENTERO 900Catalog number
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Lot number
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Product problems
- Insufficient Device Problem Information
Patient
7 MO
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
NEUROSURGERY CASE LASTING 8 HOURS. A (B)(6) MONTH OLD FEMALE PATIENT RECEIVED A BURN ON THE PERIMETER OF THE SURGICAL SITE, APPROXIMATELY 2.5" SQUARE AREA. BURN WAS NOT REALIZED UNTIL THE NEXT DAY. REPORTED AS A 1ST DEGREE BURN.IT IS NOT CLEAR WHAT THE MICROSCOPE SETTINGS THAT WERE USED DURING THE CASE, SOME OF THE MANUFACTURER PRECAUTIONARY SETTINGS ARE BELIEVED TO HAVE BEEN ADJUSTED "OUT OF THE WAY", THUS ALLOWING FOR A HIGH INTENSITY LIGHT OUTPUT.