FDA Adverse Event
Malfunction
Summary report: N
5.5 MM SHORT SECONDARY PORT
MDR report key: 3883189
·
Received February 19, 2014
Report
- Report Number
- 9612501-2014-00044
- Event Type
- Malfunction
- Date Received
- February 19, 2014
- Date of Event
- January 20, 2014
- Report Date
- February 6, 2014
- Manufacturer
- COVIDIEN
- Product Code
- GCJ
- PMA / PMN Number
- K981941
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LAP HERNIA. ACCORDING TO THE REPORTER: DURING THE PROCEDURE A PORTION OF THE WHITE SEAL FROM THE PORT BECAME DETACHED AND FELL INTO THE PT. SEAL REMOVED USING A GRASPER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105904 | 5.5 MM SHORT SECONDARY PORT | DISPOSABLE SURGICAL ACCESS DEVICE | GCJ | COVIDIEN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |