FDA Adverse Event
Injury
Summary report: N
ENDO GIA ROTICULATOR* 60-3.5 SULU
MDR report key: 4162297
·
Received October 10, 2014
Report
- Report Number
- 1219930-2014-00929
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- September 12, 2014
- Report Date
- September 15, 2014
- Manufacturer
- COVIDIEN, FORMERLY US SURGICAL A DIVISON
- Product Code
- GDW
- PMA / PMN Number
- K900129
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CI
- Reporter Occupation
- PHYSICAL THERAPIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THREE RELOADS WERE FIRED SUCCESSFULLY. WHEN ATTEMPTING TO FIRE THE FOURTH RELOAD, THE STAPLES DID NOT FORM THE PROPER B SHAPE AND FELL INTO THE ABDOMINAL CAVITY, PRODUCING BLEEDING. THE KNIFE STILL CUT THE TISSUE. THE STAPLE LINE WAS REINFORCED USING VLOC. TO COMPLETE THE PROCEDURE, A NEW EGIA RELOAD WAS USED. THE PATIENT IS CURRENTLY IN GOOD CONDITION. NO REINFORCEMENT MATERIAL WAS USED. THERE WAS NO DELAY IN SURGERY OVER THIRTY MINUTES. NO DEVICE FRAGMENT FELL INTO THE PATIENT CAVITY. EGIAUSTND: PRODUCT LOT #: P4C0322X, EGIA ULTRA UNIVERSAL STAPLER: K083519.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640145 | ENDO GIA ROTICULATOR* 60-3.5 SULU | DISPOSABLE SURGICAL STAPLING DEVICE | GDW | COVIDIEN, FORMERLY US SURGICAL A DIVISON | 030458 | N4A0691LX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PRODUCT NUMBER: EGIAUSTND |