OPMI PICO
Received Sep 12, 2024 · Event occurred Jun 13, 2024
Report 9615010-2024-00008 · MDR key 20208797
Device
Generic name
Microscope, Surgical, General & Plastic Surgery
Manufacturer
Carl Zeiss Meditec Ag (jena)Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Bruise/Contusion
- Swelling/ Edema
- Bruise/Contusion
- Swelling/ Edema
Narrative
Additional Manufacturer Narrative
DESCRIPTION OF CHANGES: FIELD B4: ADDED "DATE OF THIS REPORT" 04/03/2025. FIELD G3: UPDATED "DATE RECEIVED BY MANUFACTURER" TO "04/01/2025". 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 3201 AND 4248, ADDED " INVESTIGATION CONCLUSION" CODE 18. ADDED "INVESTIGATION CONCLUSION" CODE 4316. PREFERRED TERM: COMBINATION OF FACTORS. FIELD H11: ADDED DESCRIPTION OF CHANGES. FILE ATTACHMENTS: ATTACHED DEVICE EVALUATION.
Description of Event or Problem
A CUSTOMER REPORTED THAT WHEN A PATIENT WAS HAVING HER EARS CLEANED, THE YOKE ON THE OPMI PICO CAME UNCOUPLED AND THE SCOPE'S ARM FELL ON THE PATIENT. THE PATIENT WAS HIT IN THE MIDLINE FOREHEAD, WHICH CAUSED A CONTUSION TO THE HEAD AND SWELLING FROM THE SCALP TO THE HAIRLINE. IT IS UNCLEAR WHETHER THE PATIENT RECEIVED ANY AFTER TREATMENT DUE TO THE REPORTED INCIDENT. NO OTHER INFORMATION WAS PROVIDED.