FDA Adverse Event
Malfunction
Summary report: N
CONTOUR CURVED CUTTER STAPLER
MDR report key: 1070631
·
Received July 1, 2008
Report
- Report Number
- 3005075853-2008-00228
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 9, 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
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, AFTER THE DEVICE WAS FIRED, ONLY ONE ROW OF STAPLES HAD BEEN FIRED ON EACH SIDE. ANOTHER SAME LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTOUR CURVED CUTTER STAPLER | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4KJ9K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |