FDA Adverse Event
Injury
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR
MDR report key: 579825
·
Received March 9, 2005
Report
- Report Number
- 1527736-2005-01108
- Event Type
- Injury
- Date Received
- March 9, 2005
- Date of Event
- October 5, 2004
- Report Date
- February 15, 2005
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GCJ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED VIA A USER FACILITY MEDWATCH 1033912 THAT DURING LAPAROSCOPIC SURGERY INTRA ABDOMINAL HEMORRHAGE OCCURRED AFTER ENDOMECHANICAL STAPLING OF RENAL ARTERY. CASE WAS CONVERTED TO OPEN NEPHRECTOMY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR | ENDO LINEAR CUTTERS - ETS45MM | GCJ | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | V4022K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |