FDA Adverse Event
Injury
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 1184211
·
Received October 2, 2008
Report
- Report Number
- 3005075853-2008-02051
- Event Type
- Injury
- Date Received
- October 2, 2008
- Date of Event
- September 5, 2008
- Report Date
- September 8, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K040038
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 10/02/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WOULD NOT OPEN AFTER THE THIRD FIRING. THEY HAD TO CUT THE DEVICE OUT OF THE TISSUE. THE DR WAS ALREADY NOT GOING TO PUT THE PT BACK TOGETHER. THE PROCEDURE WAS PROLONGED TEN TO FIFTEEN MINUTES LONGER, BUT THERE WAS NO PT CONSEQUENCE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR CURVED CUTTER STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |