FDA Adverse Event
Injury
Summary report: N
ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,45MM STAPLE LINE - 2.5
MDR report key: 1181188
·
Received September 30, 2008
Report
- Report Number
- 3005075853-2008-01990
- Event Type
- Injury
- Date Received
- September 30, 2008
- Date of Event
- September 3, 2008
- Report Date
- September 4, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN APPENDECTOMY PROCEDURE, THERE WAS AN UNKNOWN PRODUCT FAILURE. ANOTHER SAME LIKE DEVICE WAS USED, THE PROCEDURE WAS CONVERTED TO OPEN. THE DEVICE WAS DISCARDED. THE PATIENT IS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH ETS FLEX45 ENDOSCOPIC ARTICULATING LINEAR CUTTER,45MM STAPLE LINE - 2.5 | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4KK2Y |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NP | Required Intervention |