N
Patient 1
THE EVENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.
MAUDE MDR 6664697
- MDR report key
- 6664697
- Report number
- 2027111-2017-01866
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-05-29
- Date received
- 2017-06-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- WENDY KOBAYASHI
- Address
- 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US
- Phone
- 949-949-9497
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | C8501, S ALEXIS LAP SYS 6/BX | KGW | APPLIED MEDICAL RESOURCES | KGW | C8501 | 101357001 | 1280459 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-23 | 0 |
Event Narratives#
D
Patient 1
LAP. PROXIMAL GASTRECTOMY - "SHEATH WAS TORN DURING THE SURGERY". TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: NO PATIENT INJURY OR RELATED ILLNESS.