FDA Adverse Event
Malfunction
Summary report: N
DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX
MDR report key: 3113213
·
Received May 8, 2013
Report
- Report Number
- 2027111-2013-00164
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Date of Event
- April 23, 2013
- Report Date
- May 7, 2013
- Manufacturer
- APPLIED MEDICAL
- Product Code
- FZP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, 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 CHOLE: "CLIP APPLIER MISFIRED DURING CASE. CLIP DID NOT CLOSE PROPERLY AROUND THE DUCT. OCCURRED TWICE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200289 | DIRECT DRIVE DISPOSABLE CLIP APPLIER 10MM 3/BOX | NONE | FZP | APPLIED MEDICAL | CA090 | 1190181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |