OPMI PICO ON S100 FLOORSTAND
Received Aug 25, 2017 · Event occurred Apr 5, 2017
Report 9615010-2017-00008 · MDR key 6822961
Device
Generic name
Opmi Pico
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
NACatalog number
000000-1095-094
Lot number
NA
Product problems
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Laceration(s)
- Laceration(s)
Narrative
Additional Manufacturer Narrative
A ZEISS FIELD SERVICE ENGINEER (FSE) PERFORMED AN ON-SITE INSPECTION OF THE MICROSCOPE. THE FSE DETERMINED THAT THE BINOCULAR TUBE FELL AS A RESULT OF A LOOSE SECURING SCREW, WHICH HAD NOT BEEN SUFFICIENTLY TIGHTENED BY THE USER, AND NOT AS A RESULT OF A DEVICE MALFUNCTION. IT WAS CONCLUDED THAT THE USER DID NOT CHECK AND FIRMLY TIGHTEN THE SECURING SCREW BEFORE USING THE MICROSCOPE. THE USER MANUAL (G-30-1781-EN, VERSION 6.0, PAGES 14, 97, 102, 137) GIVES CLEAR INSTRUCTION TO MAKE SURE THAT ALL ACCESSORIES ARE SECURELY MOUNTED. THE USER HAS BEEN REINFORMED ABOUT THE IMPORTANCE OF PERFORMING SAFETY AND FUNCTION CHECKS BEFRORE EVERY USE OF THE MICROSCOPE.
Description of Event or Problem
THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT DURING A SURGICAL PROCEDURE, THE BINOCULAR TUBE WITH EYEPIECES WAS LOOSE AND FELL OFF THE MICROSCOPE. THE BINOCULAR TUBE MADE CONTACT WITH THE HCP BEFORE FALLING TO THE FLOOR AND BREAKING. THE HCP SUFFERED A LACERATION ON THE HEAD, WHICH REQUIRED MEDICAL TREATMENT. THE HCP WAS ABLE TO FINISH THE PROCEDURE SUCCESSFULLY WITH NO NEGATIVE IMPACT TO THE PATIENT.
Remedial action
- Inspection
- Other