FDA Adverse Event
Injury
Summary report: N
EEA 28MM SINGLE-USE STAPLER
MDR report key: 4578307
·
Received March 6, 2015
Report
- Report Number
- 2647580-2015-00164
- Event Type
- Injury
- Date Received
- March 6, 2015
- Date of Event
- February 6, 2015
- Report Date
- February 13, 2015
- Manufacturer
- COVIDIEN, FORMERLY USSC PUERTO RICO INC
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INITIAL REPORT SENT TO FDA ON 03/06/2015.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: STAPLES DID NOT DEPLOY. A STOMA WAS NECESSARY IN ORDER TO COMPLETE THE SURGERY. THERE WAS A COLOSTOMY PERFORMED. THERE WAS INTRA-OPERATIVE BLEEDING. THERE WAS UNANTICIPATED TISSUE LOSS. THERE WAS AN EXTENSION OF SURGERY TIME MORE THAN 30 MINUTES. THERE WAS NO BLEEDING OVER 500CC. THE PATIENT UNDERWENT AN EXTENSION OF HOSPITAL STAY. THERE WAS NO REINFORCEMENT MATERIAL USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 157490 | EEA 28MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY USSC PUERTO RICO INC | EEA28 | P2K0340X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Other |