FDA Adverse Event
Injury
Summary report: N
ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING
MDR report key: 700232
·
Received April 17, 2006
Report
- Report Number
- 1527736-2006-01680
- Event Type
- Injury
- Date Received
- April 17, 2006
- Date of Event
- March 22, 2006
- Report Date
- March 24, 2006
- Manufacturer
- ETHICON ENDO SURGERY, INC.(CINCINNATI)
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A LOBECTOMY PROCEDURE, THE DISTAL SIDE OF THE MEDIASTIRIC ARTERY WAS COMPLETELY STAPLED, WHILST THE PROXIMAL SIDE WAS ONLY HALF STAPLED. TO STOP BLEEDING, OPENED PERI-CARDIUM IN ORDER TO HAVE ROOM ENOUGH TO LIGATE IT. THIS LENGTHENED THE SURGERY BY ONE HOUR. PATIENT CONDITION IS OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING | GDW | GCJ | ETHICON ENDO SURGERY, INC.(CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |