FDA Adverse Event
Malfunction
Summary report: N
ENDOPATH THOR ENDO LIN CUT THK
MDR report key: 1112769
·
Received August 12, 2008
Report
- Report Number
- 3005075853-2008-01116
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- May 15, 2008
- Report Date
- July 24, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE DEVICE CUT, BUT DID NOT STAPLE. THERE WAS NO REPORTED PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH THOR ENDO LIN CUT THK | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4KDGE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |