S88 / OPMI LUMERA T
Received Dec 20, 2024 · Event occurred Dec 4, 2024
Report 9615010-2024-00011 · MDR key 20995315
Device
Product problems
- Unstable
- Unstable
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 03/07/2025. FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" TO "03/05/2025". FIELD G6: CHECKED "30 DAYS", UPDATED TO "FOLLOW-UP, # 1". FIELD H2: CHECKED "DEVICE EVALUATION." FIELD H3: UPDATED "DEVICE EVALUATED BY MANUFACTURER?" TO "YES". FIELD H6: ADDED "TYPE OF INVESTIGATION" CODE 10, ADDED "INVESTIGATION FINDINGS" CODE 213, ADDED " INVESTIGATION CONCLUSION" CODE 67, AND CODE 4315. FIELD H11: ADDED DESCRIPTION OF CHANGES. FILE ATTACHMENTS: ATTACHED DEVICE EVALUATION.
Additional Manufacturer Narrative
FINAL ROOT CAUSE ANALYSIS WILL BE PERFORMED UPON MANUFACTURER INVESTIGATION OF THE RETURNED PARTS.
Description of Event or Problem
A CUSTOMER FROM SPAIN REPORTED THAT THE MICROSCOPE HEAD BROKE OFF FROM THE MICROSCOPE ARM WHILE A PATIENT WAS UNDER IT. THE DOCTOR CAUGHT THE MICROSCOPE HEAD BEFORE IT COULD HIT THE PATIENT. ISSUE OCCURRED DURING PREPARATION FOR SURGERY. THE PROCEDURE WAS CANCELED. THERE WAS NO INJURY TO ANYONE PRESENT AT THE TIME OF THE INCIDENT. NO AFTER-TREATMENT WAS NECESSARY.