FDA Adverse Event
Injury
Summary report: N
PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM
MDR report key: 3012802
·
Received March 20, 2013
Report
- Report Number
- 3005075853-2013-01315
- Event Type
- Injury
- Date Received
- March 20, 2013
- Date of Event
- February 22, 2012
- Report Date
- February 25, 2013
- 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST OP OF A COLON REVERSAL PROCEDURE THE PATIENT WAS RETURNED TO THE OPERATING ROOM A FEW DAYS LATER FOR AN ADDITIONAL PROCEDURE. THE SURGEON OBSERVED MALFORMED STAPLES DURING THE REOP IN THE MEDIAL AREA OF THE STAPLE LINE AND A LEAK. A SECOND PROCEDURE WAS PERFORMED AND THE PATIENT WAS STABLE. THE DEVICE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 116483 | PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | RELOAD XR60B |