FDA Adverse Event
Summary report: N
ENDO GIA ROTICULATOR 60-3.5 SULU
MDR report key: 1032501
·
Received April 18, 2008
Report
- Report Number
- 1219930-2008-00310
- Date Received
- April 18, 2008
- Date of Event
- April 7, 2008
- Report Date
- April 15, 2008
- Manufacturer
- NORTH HAVEN - USS
- Product Code
- GDW
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE SURGEON FIRED THE DEVICE ACROSS THE SIGMOID COLON AND THE DEVICE CUT. THE STAPLE LINE WAS EXAMINED AND IT WAS NOTICED ALL THE STAPLES FIRED IN A "TRIANGLE" SHAPE. SURGEON DID NOT REMOVE THE ORIGINAL STAPLES, OPENED A NEW DEVICE AND FIRED BELOW THE ORIGINAL STAPLE LINE AGAIN. THE SAME THING OCCURRED WITH THE SECOND LOAD. SURGEON THEN SUCTIONED ALL THE LOOSE STAPLES FROM THE CAVITY. A COMPETITIVE DEVICE WAS OPENED AND USED FOR THE REMAINDER OF THE PROCEDURE. OPERATING ROOM TIME WAS EXTENDED APPROXIMATELY 20 MINUTES. NO BLEEDING OCCURRED. ADDITIONAL INFORMATION RECEIVED VIA TELEPHONE CALL FROM THE SALES REP STATED THE ADDITIONAL STAPLE APPLICATION RESULTED IN TISSUE LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA ROTICULATOR 60-3.5 SULU | NONE | GDW | NORTH HAVEN - USS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |