FDA Adverse Event
Malfunction
Summary report: N
ETS 45 ENDO LIN CUT RELOAD GR
MDR report key: 1203795
·
Received October 10, 2008
Report
- Report Number
- 3005075853-2008-02288
- Event Type
- Malfunction
- Date Received
- October 10, 2008
- Date of Event
- September 17, 2008
- Report Date
- September 19, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 A LAP LOW ANTERIOR RESECTION PROCEDURE, THE CUT LINE AT THE PART WHICH HAD TO BE RESECTED (REMOVED) HAD NO STAPLES AND WAS OPEN. THIS LED TO THE SPILLAGE OF THE CONTENTS. THE RESECTION WAS COMPLETED WITH TWO MORE FIRINGS WITH THE SAME DEVICE WHICH FUNCTIONED PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS 45 ENDO LIN CUT RELOAD GR | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |