OPMI PENTERO 900
Received Dec 7, 2018 · Event occurred Nov 9, 2018
Report 9615010-2018-00015 · MDR key 8143094
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
NACatalog number
302582-9902-000
Lot number
NA
Product problems
- Use of Incorrect Control/Treatment Settings
- Use of Device Problem
- Use of Incorrect Control/Treatment Settings
- Use of Device Problem
Patient
Not reported
- Superficial (First Degree) Burn
- Partial thickness (Second Degree) Burn
- Superficial (First Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION WAS NOT PERFORMED BECAUSE THE OPMI PENTERO 900 MICROSCOPE WAS SERVICED 3 WEEKS PRIOR TO THE INCIDENT AND NO ISSUES WERE IDENTIFIED. IN ADDITION, THE CUSTOMER COMMUNICATED THAT THE ISSUE WAS NOT CAUSED DUE TO ANY MALFUNCTION OF THE MICROSCOPE.
Description of Event or Problem
A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT RECEIVED A 1ST TO 2ND DEGREE BURN DURING A SPINAL SURGERY WHILE USING AN OPMI PENTERO 900 MICROSCOPE. THE BURN WAS EGG-SIZED AND WITHIN THE PROXIMITY OF THE SURGICAL AREA. THE HCP TREATED THE PATIENT'S BURN WITH A GREASE PAD. THE HCP COMMUNICATED THAT THE ISSUE WAS NOT AS A RESULT OF ANY MALFUNCTION WITH THE MICROSCOPE. THE HCP REPORTED THAT THE FOCUS LIGHT LINK WAS PURPOSELY SWITCHED OFF PRIOR TO THE SURGERY WHICH COMPROMISED A SAFETY MEASURE OF THE MICROSCOPE.