FDA Adverse Event
Malfunction
Summary report: N
45MM ARTICNG LNR CUTR LONG
MDR report key: 593869
·
Received April 19, 2005
Report
- Report Number
- 1527736-2005-01752
- Event Type
- Malfunction
- Date Received
- April 19, 2005
- Date of Event
- April 1, 2005
- Report Date
- April 1, 2005
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- KOG
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRIC BYPASS WITH ROUX-EN Y PROCEDURE, AS THE SURGEON WAS MAKING 1ST TRANSECTION ACROSS THE STOMACH TO MAKE THE POUCH, DEVICE FIRED AS USUAL WITH NO INDICATION OF PROBLEM. WHEN RELEASED, IT WAS NOTICED THAT THE STAPLES AT THE DISTAL TIP HAD NOT FORMED PROPERLY AND EXPOSED THE STOMACH. USED GREEN RELOAD TO REDO STAPLE LINE. THERE WAS NO PT CONSEQUENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 45MM ARTICNG LNR CUTR LONG | ENDO LINEAR CUTTERS - ETS45MM | KOG | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |