FDA Adverse Event
Injury
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 4
MDR report key: 823880
·
Received March 5, 2007
Report
- Report Number
- 1527736-2007-01265
- Event Type
- Injury
- Date Received
- March 5, 2007
- Date of Event
- December 13, 2006
- Report Date
- February 8, 2007
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE OR TWO DAYS POST OP OF AN APEX LUNG RESECTION, THE SUTURE ON THE LUNG APEX OPENED UP AND SHOWED THAT THE CLIPS WERE NOT PROPERLY APPLIED. THE PT WAS DRAINED WITH A TORAX DRAINAGE, BUT THERE WAS AIR LEAKAGE. AFTER ONE MO, A NEW SURGERY BECAME NECESSARY. THE PT WAS SUTURED BY HAND. NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, 4 | GDW | GCJ | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | C4E96G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |