FDA Adverse Event
Injury
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1021974
·
Received March 18, 2008
Report
- Report Number
- 1527736-2008-01603
- Event Type
- Injury
- Date Received
- March 18, 2008
- Date of Event
- February 21, 2008
- Report Date
- February 22, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 03/18/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP NEPHRECTOMY, THE DEVICE STAPLED ACROSS THE RENAL ARTERY, BUT WHEN THEY WENT TO REMOVE THE DEVICE, IT TORE THE VENA CAVA WHEN THE STAPLES DID NOT HOLD. PATHOLOGY WAS INCONCLUSIVE REGARDING STAPLE FORMATION. THE SURGEON GRABBED THE VENA CAVA TO STOP THE BLEEDING CREATED BY THE HOLE. VERY MINIMAL BLOOD LOSS. CALLED IN A VASCULAR SURGEON TO COMPLETE THE CASE. THE CASE WAS CONVERTED TO OPEN TO REPAIR THE DAMAGE. PATIENT IS FINE WITH NO POST OPERATIVE ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER | GDW | ETHICON ENDO-SURGERY, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |