OPMI PENTERO
Received Jan 9, 2020 · Event occurred Nov 1, 2019
Report 9615010-2020-00001 · MDR key 9571284
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
N/ACatalog number
000000-0480-801
Lot number
N/A
Product problems
- Vibration
- Vibration
Patient
Not reported
- No Information
- No Information
Narrative
Additional Manufacturer Narrative
CZMI BECAME AWARE OF THE EVENT THROUGH A MANDATORY AND VOLUNTARY REPORT FORM (#(B)(4)) SUBMITTED BY THE SITE'S PATIENT SAFETY COORDINATOR. CZMI MADE FOUR ATTEMPTS TO GATHER ADDITIONAL DETAILS REGARDING THE PATIENT OUTCOME FROM THE PATIENT SAFETY COORDINATOR. A RESPONSE TO THE INQUIRIES HAS NOT BEEN RECEIVED. A REQUEST FOR A DEVICE INSPECTION WAS ALSO DECLINED BY THE SITE'S BIOMEDICAL ENGINEER.
Description of Event or Problem
A HEALTHCARE PROFESSIONAL (HCP) SUBMITTED A MANDATORY AND VOLUNTARY REPORT FORM (# (B)(4)) TO THE FDA. ACCORDING TO THE REPORT, DURING A PROCEDURE IN THE OPERATING ROOM IT WAS NOTED THAT THE VIEW THROUGH THE MICROSCOPE WAS VIBRATING UNCONTROLLABLY. ALSO ACCORDING TO THE REPORT, THE SURGEON EXPERIENCED HEADACHES AND NAUSEA DUE TO THE INSTABILITY OF THE MICROSCOPE VIEW AND DECIDED TO ABORT THE CASE DUE TO SAFETY CONCERNS FOR THE PATIENT. THE FINAL OUTCOME OF THE PATIENT IS NOT KNOWN TO CARL ZEISS MEDITEC, INC.(CZMI).