| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OPMI 1 FC ON S100 FLOOR STAND | SURGICAL MICROSCOPE | CARL ZEISS MEDITEC AG (OBERKOCHEN SITE) | EPT | NA | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-09-12 | 0 |
Patient 1
DURING A SURGICAL PROCEDURE FOR TONSILLITIS THE OPMI 1-FC MICROSCOPE HEAD AND AN INTERNAL PART OF THE TILT COUPLING SEPARATED FROM THE TILT COUPLING BODY (ATTACHED TO THE S100 FLOOR STAND) AND FELL INTO THE DOCTOR?S HANDS. THE SURGERY WAS COMPLETED USING AN ALTERNATE MICROSCOPE. NO ONE WAS INJURED.
Patient 1
A FIELD SERVICE ENGINEER EXAMINED THE TILT COUPLING AND FOUND THAT THE OUTER THREADED RING THAT SECURES THE COUPLING INTERNAL COMPONENTS TO THE COUPLING BODY WAS FULLY UNSCREWED. THIS THREADED RING IS SECURED AT THE FACTORY AND IS NOT INTENDED TO BE LOOSENED. IF THE RING BECOMES FULLY UNSCREWED, THE INTERNAL COMPONENTS (AND MICROSCOPE HEAD IF ATTACHED) ARE ABLE TO SEPARATE AND FALL OUT OF THE COUPLING BODY. AFTER CONFIRMING THERE WAS NO DAMAGE TO THE COMPONENTS, THE ENGINEER REINSTALLED THE THREADED RING WITH LOCTITE APPLIED TO THE THREADS AND TIGHTENED TO SPECIFICATION. IN A FOLLOW-UP VISIT, THE FIELD SERVICE ENGINEER FOUND THAT THE USER ADJUSTABLE INTERNAL SECURING SCREW THAT IS USED TO SECURE THE MICROSCOPE HEAD ROTATION SHAFT TO THE TILT COUPLING WAS MISSING AS WAS THE SCREW?S PROTECTIVE CAP. REPLACEMENT PARTS WERE ORDERED. THE CUSTOMER INDICATED THAT THEIR BIOMEDICAL ENGINEERING DEPARTMENT HAD PERFORMED SERVICE ON THIS MICROSCOPE ON A FEW OCCASIONS SINCE THE LAST PREVENTIVE MAINTENANCE IN (B)(4) 2011. THE TILT COUPLING INSTRUCTIONS FOR USE PROVIDES THE USER WITH DETAILED INSTRUCTIONS ON MOUNTING/DISMOUNTING OF THE TILT COUPLING TO THE STAND AND MOUNTING/DISMOUNTING OF THE MICROSCOPE ROTATING SHAFT TO THE TILT COUPLING.