OPMI VARIO 700
Received Feb 7, 2020 · Event occurred Jan 9, 2020
Report 9615010-2020-00002 · MDR key 9684665
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
N/ACatalog number
302570-9002-000
Lot number
N/A
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE DEVICE HAD A MALFUNCTION OF THE LEFT HAND-GRIP WHICH WAS KNOWN TO THE CUSTOMER BEFORE THIS INCIDENT OCCURRED. CARL ZEISS MEDITEC WAS NOT INFORMED BEFORE 9TH OF JANUARY ABOUT THE DEVICE MALFUNCTION. THE SAME DAY THE INCIDENT WAS REPORTED TO CARL ZEISS MEDITEC, A ZEISS FSE WENT ON CUSTOMER SITE AND EVALUATED THE DEVICE. ZEISS FSE WAS ABLE TO REPRODUCE THE ERROR WITH THE HAND-GRIP. THE HAND-GRIP UNIT LEFT SIDE WAS REPLACED. AFTER THE REPAIR, THE DEVICE MEETS FACTORY SPECIFICATIONS.
Description of Event or Problem
IT WAS REPORTED THAT ON (B)(6) 2020 A TOTAL FAILURE OF BOTH HAND GRIPS OCCURRED AT THE BEGINNING OF SPINE SURGERY, AN ERROR WHICH HAD OCCURRED A FEW DAYS BEFORE, ON (B)(6) 2020. PATIENT WAS UNDER ANESTHESIA FOR 30 MINUTES AND THE SURGERY WAS ABORTED. SURGERY WAS SUCCESSFULLY PERFORMED THE FOLLOWING DAY. THE PATIENT HAD TO STAY ONE DAY LONGER IN THE HOSPITAL. THERE WAS NO INJURY TO THE PATIENT DUE TO THIS INCIDENT.