N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9864556
- MDR report key
- 9864556
- Report number
- 9612501-2020-00495
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-01-08
- Date received
- 2020-03-23
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- 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 CLIP III | CLIP, IMPLANTABLE | DAVIS & GECK CARIBE LTD | FZP | 176630 | 176630 | J8L0680Y | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-23 | 0 |
Event Narratives#
D
Patient 1
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLEDOCHOLITHOTOMY, THE COUNTER NUMBER DECREASED BUT THE CLIP DID NOT COME OUT WHEN DEVICE WAS FIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.