FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE ILS CURVED CIR STAPL
MDR report key: 1211900
·
Received October 23, 2008
Report
- Report Number
- 3005075853-2008-02542
- Event Type
- Malfunction
- Date Received
- October 23, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 3, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K983536
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- 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 A RIGHT HALF-COLECTOMY PROCEDURE, HALF OF THE ANASTOMOSED TISSUE WAS UNSTAPLED. ALSO, THERE WAS A HOLE, WHICH WAS MADE WHEN THE DEVICE WAS INSERTED TO THE COLON. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE ILS CURVED CIR STAPL | GDW | ETHICON ENDO-SURGERY, LLC | NA | E4L693 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |