FDA Adverse Event
Other
Summary report: N
DIRECT DRIVE LCA
MDR report key: 1651562
·
Received April 2, 2010
Report
- Report Number
- 2027111-2010-00051
- Event Type
- Other
- Date Received
- April 2, 2010
- Date of Event
- March 24, 2010
- Report Date
- March 31, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ANTICIPATED TO RETURN, FOLLOW UP WILL BE PROVIDE UPON COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
LAP CHOLE - "CLIP APPLIER JAW BROKE OFF INSIDE PT CAUSING TITANIUM CLIP TO BEND STRAIGHT - FELL IN TISSUE AND CAUSING BLEEDING. HOSP WROTE UP AN INCIDENT REPORT." CLIP CAUSED BLEEDING - "READILY HANDLED WITH CAUTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT DRIVE LCA | NONE | GDO | APPLIED MEDICAL RESOURCES | CA090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |