FDA Adverse Event
Malfunction
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 1820606
·
Received September 12, 2007
Report
- Report Number
- 1527736-2007-06029
- Event Type
- Malfunction
- Date Received
- September 12, 2007
- Date of Event
- August 27, 2007
- Report Date
- August 30, 2007
- Manufacturer
- ETHICON ENDO SURGERY, INC (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K040038
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN LAR PROCEDURE THE STAPLE WAS UNFORMED AND SUTURING WAS PERFORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR CURVED CUTTER STAPLER | GDW | ETHICON ENDO SURGERY, INC (CINCINNATI) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |