FDA Adverse Event
Injury
Summary report: N
DST SERIES EEA ORVIL 25MM DEVICE
MDR report key: 1153280
·
Received September 8, 2008
Report
- Report Number
- 1219930-2008-00673
- Event Type
- Injury
- Date Received
- September 8, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 22, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- PMA / PMN Number
- K062850
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INITIAL REPORT SENT: 09/08/2008.
Description of Event or Problem · 1
PROCEDURE TYPE: LAPAROSCOPIC VATS ESOPHAGECTOMY. ACCORDING TO THE REPORTER: WHEN THE SURGEON INTRODUCED THE ORVIL INTO THE ESOPHAGUS, THE ANVIL SEPARATED FROM THE NG TUBE TWICE. BOTH ANVILS WERE SUCCESSFULLY REMOVED FROM THE PT. THE THIRD ATTEMPT WITH A THIRD DEVICE WAS SUCCESSFUL. SURGERY TIME WAS EXTENDED BY AN HOUR AND A HALF AS A RESULT. THE PT IS RECOVERING.
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 | U8F55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |