FDA Adverse Event
Injury
Summary report: N
ECHELON 60 ENDOPATH STAPLER
MDR report key: 1071386
·
Received July 8, 2008
Report
- Report Number
- 3005075853-2008-00299
- Event Type
- Injury
- Date Received
- July 8, 2008
- Date of Event
- February 20, 2008
- Report Date
- February 26, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K051002
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/08/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SCOPINARO PROCEDURE, THE STAPLE LINE SEEMED TO BE OKAY. AFTER 45 MINUTES, THERE WERE LEAKS AND BLEEDING. THE SURGEON REINFORCED THE STAPLE LINE WITH A CONTINUOUS SUTURING LINE. AT MIDNIGHT, THE PT CAME BACK TO THE OPERATING ROOM FOR AN ADD'L PROCEDURE BECAUSE OF CONTINOUS BLEEDING IN THE MESENTERIC. PT TENSION: 6 // HEMATOCRIT: 20 // THREE BLOOD BAGS WERE REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHELON 60 ENDOPATH STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | D4J5YU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |