FDA Adverse Event
Malfunction
Summary report: N
ARVEO 8X
MDR report key: 25160967
·
Received May 13, 2026
Report
- Report Number
- 3003974370-2026-00004
- Event Type
- Malfunction
- Date Received
- May 13, 2026
- Date of Event
- May 6, 2026
- Report Date
- May 13, 2026
- Manufacturer
- LEICA MICROSYSTEMS (SCHWEIZ) AG
- Product Code
- EPT
- UDI-DI
- 07630802405906
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PO
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW-UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING INVESTIGATION.
Description of Event or Problem · 0
LEICA MICROSYSTEMS (SCHWEIZ) AG RECEIVED A COMPLAINT FROM PORTUGAL STATING THAT AN ARVEO 8X SHUT DOWN DURING SURGERY. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 146263 | ARVEO 8X | SURGICAL MICROSCOPE | EPT | LEICA MICROSYSTEMS (SCHWEIZ) AG | 10449213 | 07630802405906 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |