FDA Adverse Event
Other
Summary report: N
DIRECT DRIVE LCA
MDR report key: 1660994
·
Received April 14, 2010
Report
- Report Number
- 2027111-2010-00053
- Event Type
- Other
- Date Received
- April 14, 2010
- Date of Event
- April 7, 2010
- Report Date
- April 9, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 - "PREPPED CLIP APPLIER BY FIRING IT 5 TIMES - 6TH CLIP WORKED FINE 7TH DIDN'T CLOSE 8TH DIDN'T CLOSE - 9 CLOSED OUT SIDE PT 10 DIDN'T CLOSE - EACH TIME HE ATTEMPTED TO PULL CLIP OFF IT TORE THE DUCT A LITTLE MORE, CREATED EXTREME BLEEDING - RESULTED IN USED OF ETHIC CLIP APPLIER." "SURGEON EXTREMELY FRUSTRATED. SURGEON FELT OUR CLIP APPLIER PUT PT AT HIS RISK PROLONGED CASE AT LEAST 3 MINUTES."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT DRIVE LCA | NONE | GDO | APPLIED MEDICAL RESOURCES | CA090 | 1108835 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |