FDA Adverse Event
Malfunction
Summary report: N
ETS FLEX ARTICNG LNR CUTR 45MM
MDR report key: 1083039
·
Received July 23, 2008
Report
- Report Number
- 3005075853-2008-00640
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 19, 2008
- Report Date
- June 26, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 07/23/2008. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC NEPHRECTOMY, THE WHITE VASCULAR LOAD FLEW OUT OF THE DEVICE. STAPLE LINE WAS REVIEWED AND STAPLES WERE NORMALLY FORMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG LNR CUTR 45MM | GDW | ETHICON ENDO-SURGERY, LLC. | NA | E4K30F |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |