FDA Adverse Event
Death
Summary report: N
RELOADABLE LINEAR CUTTER
MDR report key: 2142530
·
Received June 28, 2011
Report
- Report Number
- 3005075853-2011-02651
- Event Type
- Death
- Date Received
- June 28, 2011
- Date of Event
- April 11, 2011
- Report Date
- June 1, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ADDITIONAL INFORMATION RECEIVED ON 10/25/2011:
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER A GASTRECTOMY AND LYMPHADENECTOMY PROCEDURE, THE SURGEON STATED THAT THE STAPLE LINE OPENED ON THE SECOND DAY AFTER THE SURGERY. ONE DEVICE WILL BE DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RELOADABLE LINEAR CUTTER | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | NA | H43291 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death | RELOAD = (B)(4) |