FDA Adverse Event
Malfunction
Summary report: N
ETS FLEX ARTICNG LNR CUTR 45MM
MDR report key: 1112662
·
Received August 11, 2008
Report
- Report Number
- 3005075853-2008-01078
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 25, 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
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GASTRIC BYPASS PROCEDURE,THE DEVICE CUT BUT DID NOT STAPLE. THE SURGEON MANUALLY SUTURED THE ANASTAMOSIS BY HAND, AND COMPLETED THE PROCEDURE. TWO DAYS POST OP, THE STAPLE LINE STRICTURED, AND A RE-OPERATION WAS REQUIRED. THE PATIENT IS OKAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ETS FLEX ARTICNG LNR CUTR 45MM | GDW | ETHICON ENDO-SURGERY, LLC | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |