FDA Adverse Event
Injury
Summary report: N
ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FOR OPEN PROCE
MDR report key: 940161
·
Received November 7, 2007
Report
- Report Number
- 1527736-2007-07413
- Event Type
- Injury
- Date Received
- November 7, 2007
- Date of Event
- October 9, 2007
- Report Date
- October 9, 2007
- 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
- NV, US
- 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 DURING AN ABDOMINAL WALL AND BOWEL RESECTION PROCEDURE WITH THREE ANASTAMOSIS, ALL THREE STAPLE LINES HAD MINIMAL BLEEDING. HOWEVER, MORE THAN THE SURGEON IS ACCUSTOM TO. THE STAPLE LINES WERE OVERSEWN AND THERE WAS NO PATIENT CONSEQUENCE. THE PATIENT SUBSEQUENTLY DEVELOPED A BOWEL LEAK AND WAS TAKEN BACK INTO SURGERY IN 2007. THE PATIENT DEVELOPED SEPSIS AS RESULT OF THE LEAKAGE. A TRACH TUBE WAS PLACED AND THE PATIENT WAS SENT TO ICF UNIT. THE PATIENT REMAINS IN HOSPITAL AND IS RECOVERING WITHOUT ANY FURTHER COMPLICATIONS. THE PATIENT IS EXPECTED TO BE DISCHARGED TO A REHAB HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS COMPACT FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER FOR OPEN PROCE | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | D4HK84 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Hospitalization| L| R |