OPMI PENTERO
Received Dec 10, 2017 · Event occurred Nov 3, 2015
Report 9615010-2017-00015 · MDR key 7102956
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
NACatalog number
302582-9901-000
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
14 YR
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
THE DIFFERENT FACTORS THAT CAN INFLUENCE THE RISK OF BURN INJURIES ARE DESCRIBED IN DETAIL IN THE OPMI PENTERO USER MANUAL (G-30-1458-EN, ISSUE 9.1, PAGES 22-24). RECOMMENDATIONS FOR REDUCING THE RISK OF BURNS ARE ALSO PROVIDED.
Description of Event or Problem
THE USER FACILITY REPORTED THAT A PATIENT SUSTAINED A SECOND DEGREE BURN DURING A TYMPANOMASTOIDECTOMY PROCEDURE IN WHICH THE OPMI PENTERO MICROSCOPE WAS USED. THE BURN WAS LOCATED ON THE ANTIHELIX OF THE OPERATED EAR. THE BURN WAS SEEN AFTER SURGERY, AT THE FIRST CLINIC VISIT ON POST-OPERATIVE DAY 5. A TOPICAL ANTIBIOTIC TREATMENT (BACITRACIN) WAS ADMINISTERED.