FDA Adverse Event
Injury
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 1002983
·
Received February 5, 2008
Report
- Report Number
- 1527736-2008-00685
- Event Type
- Injury
- Date Received
- February 5, 2008
- Date of Event
- January 11, 2008
- Report Date
- January 17, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GDW
- PMA / PMN Number
- K040038
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- 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 LOW ANTERIOR RESECTION PROCEDURE, THE STAPLES AT THE DISTAL END GAVE WAY. THIS CAUSED THE SURGEON TO HAND SUTURE AND DUE TO NO MORE MARGINS, HE HAD TO CONVERT TO AN APR. ANOTHER LIKE DEVICE WAS THEN USED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR CURVED CUTTER STAPLER | GDW | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | DAG96A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |