FDA Adverse Event
Injury
Summary report: N
EEA 31MM SINGLE-USE STAPLER
MDR report key: 1153281
·
Received September 8, 2008
Report
- Report Number
- 1219930-2008-00675
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- August 20, 2008
- Report Date
- September 3, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 09/08/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: ANTERIOR RESECTION. ACCORDING TO THE REPORTER: INSTRUMENT WAS STUCK IN LOWER COLON AFTER FIRING SINCE THE ANASTOMOSIS NOT COMPLETELY CUT. THE INSTRUMENT WAS REMOVED AFTER MANUALLY CUTTING IT FREE. SOME TISSUE DAMAGE OCCURRED AS A RESULT AND THE ANASTOMOSIS WAS OVER SEWN. NO BLEEDING WAS REPORTED. TWO DAYS POST-OPERATIVELY A LEAK AT THE ANASTOMOSIS WAS NOTICED, AND A STOMA WAS SET UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 31MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | U7A11 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention |