FDA Adverse Event
Other
Summary report: N
DIRECT DRIVE LCA
MDR report key: 1586171
·
Received January 21, 2010
Report
- Report Number
- 2027111-2010-00010
- Event Type
- Other
- Date Received
- January 21, 2010
- Date of Event
- January 4, 2010
- Report Date
- January 19, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GDO
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AND EVALUATION OF THE INCIDENT DEVICE, A FINAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
"DR.(B)(6) USED 4 DEVICES AND THE CLIPS CAME OUT AND TWISTED OFF THE APPLIER BEFORE THEY COULD BE CRIMPED. DR. (B)(6) PULLED THE APPLIER OUT OF THE ABDOMEN AND IT STILL TWISTED. IT SEEMS TO HAPPEN AFTER THE 2ND OR 3RD CLIP. FOUR DEVICES WERE USED TO FINISH THE SURGERY THUS, EXTENDING ANESTHESIA TIME."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DIRECT DRIVE LCA | NONE | GDO | APPLIED MEDICAL RESOURCES | CA090 | 1102926 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |