FDA Adverse Event
Malfunction
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 1231204
·
Received November 10, 2008
Report
- Report Number
- 3005075853-2008-02913
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- October 16, 2008
- Report Date
- October 16, 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
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4). (B) (4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE SURGEON FIRED THE DEVICE, HE FOUND THAT THE BLADE CAME OUT WITHOUT THE STAPLES. HAND SEWING WAS USED TO COMPLETE THE PROCEDURE. 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 | E4LL3N |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |