FDA Adverse Event
Malfunction
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 1150961
·
Received August 28, 2008
Report
- Report Number
- 3005075853-2008-01420
- Event Type
- Malfunction
- Date Received
- August 28, 2008
- Date of Event
- August 7, 2008
- Report Date
- August 12, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K040038
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- 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 PRIOR TO A COLON RESECTION PROCEDURE, WHILE PREPARING THE DEVICE FOR CASE APPLICATION, A STAPLE IN THE DISTAL PART OF THE JAW WAS NOT COMPLETELY FORMED. THE PROCEDURE WAS PROLONGED 30 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR CURVED CUTTER STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4KR7X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |