FDA Adverse Event
Injury
Summary report: N
MIZUHO OSI HANA TABLE
MDR report key: 16953652
·
Received May 17, 2023
Report
- Report Number
- MW5117644
- Event Type
- Injury
- Date Received
- May 17, 2023
- Date of Event
- May 13, 2023
- Report Date
- May 15, 2023
- Manufacturer
- MIZUHO ORTHOPEDIC SYSTEMS, INC.
- Product Code
- JEA
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
EQUIPMENT MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 650577 | MIZUHO OSI HANA TABLE | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED | JEA | MIZUHO ORTHOPEDIC SYSTEMS, INC. | 6875 | 2015-1116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |