FDA Adverse Event
Malfunction
Summary report: N
ETS 35 ENDO LIN CTTR WHT
MDR report key: 597235
·
Received April 27, 2005
Report
- Report Number
- 1527736-2005-01842
- Event Type
- Malfunction
- Date Received
- April 27, 2005
- Date of Event
- March 30, 2005
- Report Date
- April 1, 2005
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING A LIVER RESECTION PROCEDURE, THE DEVICE FIRED FINE THE FIRS TIME. THEN, IT WAS RELOADED AND IT MISFIRED. UPON INSPECTION, THE STAPLES DID NOT CLOSE. AS A RESULT, THE PT BLED FROM THE HEPATIC VEIN. THE SURGEON HAD TO REPAIR BY HAND AND HAND-SEW BLOOD VESSELS. PROCEDURE WAS EXTENDED BY ABOUT 1 HOUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS 35 ENDO LIN CTTR WHT | ENDO LINEAR CUTTERS - ETS35MM | KOG | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | V43551 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |