N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908760
- MDR report key
- 9908760
- Report number
- 1219930-2020-01467
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-09
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- LISA HERNANDEZ
- Address
- 60 MIDDLETOWN AVE. NORTH HAVEN CT 06473 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ENDO GIA | STAPLE, IMPLANTABLE | COVIDIEN LP LLC NORTH HAVEN | GDW | EGIA45AVM | EGIA45AVM | N9E0929KY | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOBECTOMY, DURING THE THIRD SHOT THE RELOAD STOPPED. THEY WAITED FOR THE CALIBRATION OF THE HANDLE THE WHOLE PROCEDURE WAS PERFORMED FOR RECOGNITION , BUT THE RELOAD HAS NOT BEEN RECOGNIZED AND THE LIGHTS WERE FLASHING. IT WAS NECESSARY TO EXCHANGE THE RELOAD FOR ANOTHER ONE WHICH WAS RECOGNIZED AND WORKED NORMALLY. THERE WAS NO PATIENT INJURY.