FDA Adverse Event
Malfunction
Summary report: N
SYMMETRY DECKER
MDR report key: 14731300
·
Received June 17, 2022
Report
- Report Number
- 14731300
- Event Type
- Malfunction
- Date Received
- June 17, 2022
- Date of Event
- May 25, 2022
- Report Date
- June 7, 2022
- Manufacturer
- SYMMETRY SURGICAL INC.
- Product Code
- HAE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DOCTOR WHILE USING THE MICRO PITUITARY RONGEUR. THE INSTRUMENT BROKE AT THE TIP. INSTRUMENT SEQUESTERED AND CHECKED FOR COMPLETENESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203118 | SYMMETRY DECKER | RONGEUR, MANUAL | HAE | SYMMETRY SURGICAL INC. | 53-4002 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20805 DA | Unknown |