OPMI PICO ON S100 FLOOR STAND

Additional Manufacturer Narrative

NARRATIVE: THIS EMDR WAS RESUBMITTED ON 2015-11-23 BECAUSE THE ORIGINAL EMDR SUBMISSION ON 2015-08-11 DID NOT RECEIVE THE REQUIRED THREE ACKNOWLEDGEMENTS. A FIELD SERVICE ENGINEER(FSE)PERFORMED AN ON-SITE INSPECTION AND FOUND THAT THE TWO BOLTS SECURING THE XENON POWER SUPPLY ILLUMINATION UNIT MOUNTING PLATE TO THE S100 STAND WERE BROKEN. THE MICROSCOPE WAS REPAIRED AND PUT BACK INTO SERVICE. (B)(6).

Description of Event or Problem

THE HEALTH CARE PROFESSIONAL REPORTED THE FOLLOWING: WHILE ADJUSTING THE OPMI PICO MICROSCOPE ON AN S100 FLOOR STAND DURING A ROOT CANAL SURGERY, THE ILLUMINATION MODULE CAME LOOSE FROM THE SUSPENSION ARM AND BEGAN TO FALL. THE ASSISTING DOCTOR CAUGHT THE FALLING MODULE BEFORE IT HIT THE FLOOR. THE FALLING MODULE DID NOT ENTER THE PATIENT ENVIRONMENT.

Additional Manufacturer Narrative

MANUFACTURER NARRATIVE: THE BROKEN PARTS WERE SENT BACK TO THE MANUFACTURER CARL (B)(4). THE MATERIAL LABORATORY EVALUATED THE BREAK AND CONCLUDED THAT THE BOLTS BROKE DUE TO A FORCED RUPTURE, WHICH TYPICALLY OCCURS DUE TO EXCESSIVE FORCE EITHER IMPACTING DIRECTLY ONTO THE BOLTS OR INDIRECTLY BY BEING APPLIED TO THE ILLUMINATION MODULE AND BEING TRANSMITTED TO THE BOLTS. SUCH A FORCE COULD HAVE IMPACTED TO THE BOLTS A REASONABLE TIME PRIOR TO WHEN THE INCIDENT OCCURRED. THE EXACT CAUSE WHY THE BOLTS BROKE CANNOT BE DETERMINED. ZEISS RECORDS INDICATE THAT THE MICROSCOPE IN QUESTION HAS NOT BEEN SERVICED BY ZEISS SINCE THE INSTALLATION IN 2013. THE MANUFACTURER REVIEWED THE ASSEMBLY PROCESS OF THE RELATED MODULE AND CONFIRMED THAT THE ASSEMBLY IS CONTROLLED WITH A TORQUE SPECIFICATION AND THE USE OF A CALIBRATED TOOL. THE INSPECTION OF THE CURRENT LOT OF SCREWS DID NOT SHOW ANY ABNORMALITY. THE DEVICE HISTORY RECORDS DO ALSO NOT SHOW ANY ABNORMALITIES. THE RISK OF DEFECTIVE BOLTS AND THE POTENTIAL OF A FALLING SYSTEM IS CONSIDERED IN THE RISK ANALYSIS (MS-3RDE-0062, V8, POINT 6.8). THE TREND FOR THIS PARTICULAR FAILURE MODE DOES NOT SHOW ANY NEGATIVE TREND. THE USER MANUAL (G_30_1781_V6_0_EN_2013) INSTRUCTS THE USER ON PAGE 12 TO PERFORM THE FOLLOWING SAFETY MEASURES: " IN ORDER TO PREVENT ANY IMPAIRMENT OF THE DEVICE'S SAFETY DUE TO AGE, WEAR, ETC., THE USER MUST ENSURE THAT THE DEVICE IS SUBJECTED TO THE NECESSARY SAFETY CHECKS" AND ON PAGE 265 THE FOLLOWING CAUTION IS STATED: "RISK OF INJURY! MAKE SURE THAT THE REGULAR TECHNICAL SAFETY CHECKS REQUIRED FOR THIS SYSTEM IN ACCORDANCE WITH THE APPLICABLE NATIONAL REGULATIONS ARE PERFORMED ON SCHEDULE AND TO THE STIPULATED EXTENT. ... THE SAFETY CHECKS SHALL ONLY BE PERFORMED BY THE MANUFACTURER OR BY QUALIFIED STAFF". (B)(4).

Description of Event or Problem

NA