FDA Adverse Event
Injury
Summary report: N
DST SERIES EEA ORVIL 25MM DEVICE
MDR report key: 1163126
·
Received September 16, 2008
Report
- Report Number
- 1219930-2008-00689
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- May 23, 2008
- Report Date
- September 8, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INTIIAL REPORT SENT: 09/16/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: GASTRECTOMY. ACCORDING TO THE REPORTER: THE ORVIL ANVIL BECAME STUCK AND DISENGAGED WHILE IN THE PATIENT'S ESOPHAGUS. THE ANVIL WAS REMOVED USING A GASTROSCOPE AND BIOPSY FORCEPS. NO TRAUMA OR TISSUE DAMAGE TO PATIENT OCCURRED AND THE ANASTOMOSIS WAS HAND SEWN. THERE WAS NO BLOOD LOSS AND NO REQUIREMENT FOR A BLOOD TRANSFUSION. SURGERY TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES AS A RESULT. A POST-OPERATIVE BILE LEAK WAS OBSERVED FROM THE HAND SEWN ANASTOMOSIS. HOWEVER THE PATIENT IS CURRENTLY STABLE AND IS AT HOMER RECOVERING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DST SERIES EEA ORVIL 25MM DEVICE | DISPOSABLE SURGICAL STAPLER | GDW | NORTH HAVEN - USS | U7L45 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |