FDA Adverse Event
Injury
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,45MM STAPLE LINE-2.5MM
MDR report key: 1053345
·
Received May 20, 2008
Report
- Report Number
- 1527736-2008-03217
- Event Type
- Injury
- Date Received
- May 20, 2008
- Date of Event
- May 7, 2008
- Report Date
- May 9, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT FOLLOWING A LAPAROSCOPIC OOPHORECTOMY PROCEDURE, THE PATIENT WAS BROUGHT BACK INTO THE HOSPITAL. THEY REOPENED THE PATIENT AND REINFORCED THE STAPLE LINE BY SUTURING IT. THERE WAS POST-OP BLEEDING REPORTED AND THE PATIENT REQUIRED TWO BAGS OF BLOOD. SHE IS IN STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,45MM STAPLE LINE-2.5MM | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | E4KG9P |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |