FDA Adverse Event
Injury
Summary report: N
EEA 28MM SINGLE-USE STAPLER
MDR report key: 1002011
·
Received February 22, 2008
Report
- Report Number
- 1219930-2008-00172
- Event Type
- Injury
- Date Received
- February 22, 2008
- Date of Event
- January 31, 2008
- Report Date
- January 31, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GAG
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PROCEDURE TYPE: GYN. ACCORDING THE REPORTER: IT WAS HARD TO INTRODUCE THE DEVICE. DURING USE, THE SECURITY LOCK BROKE AND THE INSTRUMENT JAMMED INSIDE THE PATIENT. THE OPERATOR BELIEVES THE DEVICE WAS BROKEN EITHER BEFORE INTRODUCING IT, OR DURING INTRODUCTION AND BEFORE APPLYING IT. THE DEVICE WAS REMOVED WITHOUT DIFFICULTY AND THE OPERATOR USED ANOTHER INSTRUMENT. NO TISSUE LOSS OR DAMAGE, NO SIGNIFICANT BLOOD LOSS WAS REPORTED, SURGERY WAS EXTENDED BY APPROX 30 MINS. THE OPERATOR SUSPECTS A VAGINAL FISTULA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EEA 28MM SINGLE-USE STAPLER | DISPOSABLE SURGICAL STAPLER | GAG | NORTH HAVEN - USS | U7M05H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Hospitalization| R |