FDA Adverse Event
Injury
Summary report: N
ENDOPATH** ETS45
MDR report key: 1961374
·
Received January 14, 2011
Report
- Report Number
- 3005075853-2011-00180
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- September 27, 2010
- Report Date
- December 23, 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
- SW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT POST OP A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE PATIENT WAS RE-OPERATED AFTER THE LGBP AND THERE WAS BLEEDING IN THE STAPLE LINE WHERE THE SMALL INTESTINE WAS DIVIDED. SUTURING WAS USED ON THE STAPLE LINE. NO ADVERSE CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SENT VIA SUPPLEMENTAL REPORT UPON RECEIPT.
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 |