FDA Adverse Event
Injury
Summary report: N
EEA 31MM SINGLE-USE STAPLER
MDR report key: 3940842
·
Received July 7, 2014
Report
- Report Number
- 2647580-2014-00503
- Event Type
- Injury
- Date Received
- July 7, 2014
- Report Date
- June 13, 2014
- Manufacturer
- COVIDIEN, FORMELRY USSC
- Product Code
- GAG
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE TYPE: COLORECTAL. ACCORDING TO THE REPORTER: TWENTY FOUR HOURS AFTER SURGERY, DURING THE POST OPERATIVE PERIOD, PT HAD PRESENTED BLEEDING OF MORE THAN 500CC. THE PT RECEIVED A TRANSFUSION AND INTERVENTION. USED AN ENDOSCOPE TO CONFIRM THAT THE STAPLE LINE WAS OPENED AND THEN SCLEROSED THE VESSELS TO STOP THE BLEEDING. THERE WAS AN EXTENSION OF HOSPITAL STAY. THERE WAS UNANTICIPATED TISSUE LOSS AND TISSUE DAMAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393104 | EEA 31MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GAG | COVIDIEN, FORMELRY USSC | P3M0313KX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |