FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM
MDR report key: 590929
·
Received June 3, 2004
Report
- Report Number
- 1527736-2004-01568
- Event Type
- Malfunction
- Date Received
- June 3, 2004
- Date of Event
- May 10, 2004
- Report Date
- May 10, 2004
- Manufacturer
- ETHICON ENDO-SURGERY, INC.(CINCINNATI)
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE, ON THE THIRD FIRING, 1/4 OF THE STAPLE LINE HAD FIRED FINE, BUT EHE NEXT 1/3 THE STAPLES HAD NOT FORMED AT ALL. IT CUT, BUT DID NOT STAPLE. THE STAPLES THAT WERE MALFORMED WEE PULLED OUT OF THE TISSUE. EXTENDED OR TIME BY TWO HOURS. NO FURTHER PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS45 ENDOSCOPIC LINEAR CUTTER - 2.5 MM | ENDO LINEAR CUTTERS - ETS 45MM | KOG | ETHICON ENDO-SURGERY, INC.(CINCINNATI) | NA | V4Z461 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |