FDA Adverse Event
Injury
Summary report: N
ENDOPATH** ETS45
MDR report key: 1726516
·
Received June 17, 2010
Report
- Report Number
- 3005075853-2010-03289
- Event Type
- Injury
- Date Received
- June 17, 2010
- Date of Event
- May 6, 2010
- Report Date
- May 27, 2010
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B) (4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THERE WAS NOTHING REMARKABLE THAT HAPPENED DURING THE PROCEDURE. THE CASE WAS COMPLETED AND THE ANASTOMOSIS WAS TESTED WITH NO LEAK. THE NEXT DAY (B) (6) 2010 THE PATIENT PRESENTED WITH A GJ ANASTOMOSIS LEAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH** ETS45 | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |