FDA Adverse Event
Malfunction
Summary report: N
BLADELESS VP 12MM ST W/ FIXATION
MDR report key: 3172858
·
Received May 30, 2013
Report
- Report Number
- 2647580-2013-00298
- Event Type
- Malfunction
- Date Received
- May 30, 2013
- Report Date
- May 8, 2013
- Manufacturer
- COVIDIEN
- Product Code
- GCJ
- PMA / PMN Number
- K081169
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: DURING THE PROCEDURE THE TROCAR WAS LEAKING. AFTER THE CASE WAS COMPLETED, IT WAS DETERMINED THAT THE SEAL HAD A TEAR IN IT.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER: DURING THE PROCEDURE, THE TROCAR WAS LEAKING. AFTER THE CASE WAS COMPLETED, IT WAS DETERMINED THAT THE SEAL HAD A TEAR IN IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 239619 | BLADELESS VP 12MM ST W/ FIXATION | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | COVIDIEN | NB12STF |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |