FDA Adverse Event
Malfunction
Summary report: N
CRILE V. MUELLER
MDR report key: 7880813
·
Received September 17, 2018
Report
- Report Number
- 7880813
- Event Type
- Malfunction
- Date Received
- September 17, 2018
- Date of Event
- August 16, 2018
- Report Date
- September 11, 2018
- Manufacturer
- MCKESSON TECHNOLOGIES, INC.
- Product Code
- GDJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING SURGERY THE TIP OF THE KELLY CLAMP BROKE OFF 1 INCH. IDENTIFIED IMMEDIATELY. NO FB (FOREIGN BODY) RETAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724055 | CRILE V. MUELLER | SURGICAL CLAMP | GDJ | MCKESSON TECHNOLOGIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18615 DA |