FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE ILS CURVED CIR STAPL
MDR report key: 1080520
·
Received July 24, 2008
Report
- Report Number
- 3005075853-2008-00414
- Event Type
- Malfunction
- Date Received
- July 24, 2008
- Date of Event
- March 20, 2008
- Report Date
- June 19, 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
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT: 7/11/2008. INFO ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE DEVICE WAS INSERTED TO ANASTOMOSES THE COLON TO THE RECTUM. THE ANVIL OF THE DEVICE WAS ATTACHED TO THE INTEGRAL TROCAR AND THE DEVICE WAS CLOSED. THE INDICATOR REACHED THE MAXIMUM CLOSURE IN THE GAP SETTING SCALE, BUT IT FELT AS IF THE DEVICE WAS NOT FULLY CLOSED. THE DEVICE WAS REMOVED AND A NEW CIRCULAR STAPLER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE ILS CURVED CIR STAPL | NONE | GDW | ETHICON ENDO-SURGERY, LLC | NA | D4JY00 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |