FDA Adverse Event
Malfunction
Summary report: N
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
MDR report key: 3181636
·
Received June 14, 2013
Report
- Report Number
- 2027111-2013-00221
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 24, 2013
- Report Date
- June 10, 2013
- Manufacturer
- APPLIED MEDICAL
- Product Code
- GDO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT IS BEING RETURNED FOR EVAL BUT LOT NUMBER IS PROVIDED. A DEVICE HISTORY REPORT IS TO BE REVIEWED BY ENGINEERING. A FINAL REPORT WILL BE SENT ONCE THE RESULTS HAVE BEEN ANALYZED. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFO WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.
Description of Event or Problem · 1
LAP HELLAR - "SURGEON SAID THE CLIP WOULD NOT FULLY CLOSE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271015 | DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX | NONE | GDO | APPLIED MEDICAL | CA090 | 1190640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |