FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER
MDR report key: 614135
·
Received June 2, 2005
Report
- Report Number
- 1527736-2005-02343
- Event Type
- Malfunction
- Date Received
- June 2, 2005
- Date of Event
- May 12, 2005
- Report Date
- May 20, 2005
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE AFTER SECOND RELOAD, ALL LOOKED FINE. ANESTHESIOLOGIST PLACED TUBE DOWN STOMACH AND WENT THROUGH THE STAPLE LINE. THE STAPLES WERE COMPLETELY UNFORMED FROM "B" TO STRAIGHT LINE. THE CASE WAS COMPLETED USING THE SAME DEVICE AND SUTURES. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH FLEX45 ARTICULATING ENDOSCOPIC LINEAR CUTTER | ENDOSCOPIC LINEAR CUTTERS | KOG | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |