FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE RELOADABLE LINEAR STAPLER - 30 MM
MDR report key: 1081884
·
Received July 22, 2008
Report
- Report Number
- 3005075853-2008-00612
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 25, 2008
- Report Date
- June 27, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, LLC
- Product Code
- GDW
- PMA / PMN Number
- K020779
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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 COLECTOMY PROCEDURE, THE DEVICE WAS BEING USED TO CLOSE THE OTOMY CREATED ON A SIDE-TO-SIDE ANASTOMOSIS. THE PIN WAS PLACED AND CLOSED TO THE INTERMEDIATE FIRING POSITION, BUT WHEN THE DEVICE WAS FIRED, A LOUD CRACKING NOISE WAS HEARD. WHEN THE TISSUE WAS CUT AND THE DEVICE WAS RELEASED, IT WAS FOUND THAT NO STAPLES HAD FIRED. HAND SEWING WAS USED TO CLOSE THE OSTOMY. THERE WAS O ADVERSE CONSEQUENCE TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROXIMATE RELOADABLE LINEAR STAPLER - 30 MM | GDW | ETHICON ENDO-SURGERY, LLC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |