FDA Adverse Event
Injury
Summary report: N
PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP
MDR report key: 3131430
·
Received May 9, 2013
Report
- Report Number
- 3006451981-2013-00142
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- October 8, 2012
- Report Date
- April 17, 2013
- Manufacturer
- COVIDIEN MEDICAL PRODUCTS
- Product Code
- GDW
- PMA / PMN Number
- K001895
- Adverse Event
- Yes
- 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 TYPE: HEMICOLECTOMY. ACCORDING TO THE REPORTER: THE SURGEON PERFORMED ROUTINE END TO SIDE ANASTOMOSIS. PPCEEA 28MM THROUGH COLON TO JOIN TO SMALL BOWEL. ANASTOMOSIS PERFORMED EXTRA-CORPOREALLY AND COLON CLOSED WITH TA. BLEEDING HAS OCCURRED FROM STAPLE LINE AND PATIENT WAS RETURNED TO THEATRE WHERE ANASTOMOSIS WAS OVER SEWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204996 | PREMIUM PLUS CEEA 28 INSTR. W/TILT-TOP | DISPOSABLE SURGICAL ACCESSORY | GDW | COVIDIEN MEDICAL PRODUCTS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |