FDA Adverse Event
Injury
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 1053132
·
Received May 8, 2008
Report
- Report Number
- 1527736-2008-02844
- Event Type
- Injury
- Date Received
- May 8, 2008
- Date of Event
- April 8, 2008
- Report Date
- April 15, 2008
- Manufacturer
- ETHICON ENDO SURGERY, INC. (CINCINNATI)
- Product Code
- GAG
- PMA / PMN Number
- K040038
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, THE DEVICE STAPLED THE PROXIMAL LINE AND PRODUCED A CUT LINE, BUT FAILED TO STAPLE THE DISTAL LINE. SURGERY WAS PROLONGED 240 MINUTES AS THE SURGEON HAD TO HAND STITCH THE DISTAL LINE TRANSANALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR CURVED CUTTER STAPLER | GAG | ETHICON ENDO SURGERY, INC. (CINCINNATI) | NA | D4J071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |