FDA Adverse Event
Malfunction
Summary report: N
PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM
MDR report key: 3140455
·
Received May 31, 2013
Report
- Report Number
- 3005075853-2013-02711
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Report Date
- May 7, 2013
- 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
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TRACKING: (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION UNAVAILABLE.
Description of Event or Problem · 1
IT WAS REPORTED THE STAPLER FIRED CORRECTLY THE FIRST TIME, BUT HAD TO REVISE THE ANASTOMOSIS AS IT LOOKED A BIT DUSKY. WHEN CLOSING THE ENTEROSTOMY WITH THE DEVICE AFTER COMPLETING THE SIDE TO SIDE WITH THE CONVENTIONAL CUTTER, THE STAPLER DIDN'T FIRE ANY STAPLES USING A BLUE RELOAD. A NEW LOAD WAS PLACED AND ONCE MORE THE STAPLER DID NOT STAPLE. THE ANASTOMOSIS WAS REDONE WITH NEW DEVICE AND THE ANASTOMOSIS WENT FINE. THERE WAS NO PATIENT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241266 | PROXIMATE** RELOADABLE LINEAR STAPLER - 60 MM | STAPLE, IMPLANTABLE | GDW | ETHICON ENDO-SURGERY, LLC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |