OPMI SENSERA
Received Jul 27, 2018 · Event occurred Jun 28, 2018
Report 9615010-2018-00010 · MDR key 7729155
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (oberkochen)Model number
N/ACatalog number
000000-1183-793
Lot number
N/A
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT WHILE THE DOCTOR WAS MOVING THE OPMI SENSERA MICROSCOPE TO THE OPERATING TABLE PRIOR TO A PROCEDURE, THE OPTICAL HEAD BECAME LOOSE FROM THE SUSPENSION ARM. THE HEAD DID NOT FULLY DETACH AND WAS STILL CONNECTED TO THE ARM VIA A CABLE. THE DOCTOR WAS SUPPORTING THE HEAD ON HIS HAND WHICH PREVENTED IT FROM FALLING. NO PATIENT WAS IN THE ROOM AT THIS TIME. THE DOCTOR MOUNTED THE OPTICAL HEAD BACK ONTO THE STAND USING AN ALLEN WRENCH. THE SAME MICROSCOPE WAS USED TO COMPLETE THE SCHEDULED PROCEDURE WITH MINOR DELAY. THERE WAS NO INJURY REPORTED TO THE PATIENT, DOCTOR OR A THIRD PARTY.
Additional Manufacturer Narrative
FURTHER UPDATES BASED ON DEVICE EVALUATION: TPYE OF REPORT: UPDATED FROM "INITIAL" TO "FOLLOW-UP #: 1". FOLLOW-UP TYPE: ENTERED "DEVICE EVALUATION". EVAL BY MFR: UPDATED FROM "NO" TO "YES" AND INDICATED "EVALUATION SUMMARY ATTACHED". RESULT CODE(S): UPDATED FROM "3233" TO "3201". CONCLUSION CODE(S): UPDATED FROM "11" TO "4316". UPDATED MANUFACTURER NARRATIVE AND ADDED DESCRIPTIONS OF FURTHER UPDATES AND CORRECTED DATA. ATTACHMENT: [MDR (INITIAL REPORT)_PP_OPMI SENSERA_HEAD FELL_CI1109124_FUP_EVAL SUMMARY.PDF].