FDA Adverse Event
Malfunction
Summary report: N
ETS FLEX ARTICNG LNR CUTR 45MM
MDR report key: 1163331
·
Received September 10, 2008
Report
- Report Number
- 3005075853-2008-01630
- Event Type
- Malfunction
- Date Received
- September 10, 2008
- Date of Event
- August 29, 2008
- Report Date
- September 8, 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
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 09/10/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN EMERGENCY LATE NIGHT LAP COLON RESECTION PROCEDURE, THE DEVICE WAS FIRED WITHOUT A CARTRIDGE. THE DEVICE CUT, BUT DID NOT STAPLE. THE DEVICE WAS LOADED AND THE CASE WAS COMPLETED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG LNR CUTR 45MM | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |