OPMI 1 MICROSCOPE ON S1 STAND

Additional Manufacturer Narrative

CARL ZEISS WAS UNABLE TO INSPECT THE DEFECTIVE POWER CORD AND VERIFY THE REPORTED ISSUE AS THE HEALTH CARE PROFESSIONAL (HCP) DECLINED A SERVICE VISIT. FURTHER UPDATES BASED ON MFR EVALUATION: DATE OF REPORT: CORRECTED FROM "04/12/2017" TO "03/14/2017". DATE REC'D BY MFR: UPDATED FROM "3/14/2017" TO "9/15/2017" FOR FOLLOW UP. TYPE OF REPORT: UPDATED FROM "INITIAL" TO "FOLLOW-UP #: 1". IF FOLLOW UP, WHAT TYPE?: ENTERED "CORRECTION" AND "ADDITIONAL INFORMATION". DEVICE EVALUATED BY MFR: UPDATED FROM "DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN" TO "OTHER: USER DECLINED DEVICE EVALUATION." (B)(4).

Description of Event or Problem

THIS IS CASE TWO OF TWO REPORTED FROM THE SAME CUSTOMER SITE. THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT, THE SITE'S TECHNICIAN WAS PLUGGING THE OPMI 1 MICROSCOPE ON S1 STAND INTO THE POWER OUTLET. SHE RECEIVED AN ELECTRIC SHOCK WHEN SHE ACCIDENTLY TOUCHED THE EXPOSED WIRE OF THE PRE-DAMAGED POWER CORD (NEAR THE CONNECTOR). THE TECHNICIAN WAS NOT INJURED FROM THE EVENT. SHE DID NOT CONSULT A PHYSICIAN NOR DID SHE REQUIRE ANY MEDICAL TREATMENT.