N
Patient 1
EVALUATION CONFIRMED THAT ONE JAW HAS BROKEN OFF THE INSTRUMENT. A PROBABLE CAUSE WAS STRESS OVERLOAD; TISSUE BONE POSSIBLY TOO DENSE. WE CANNOT CONFIRM.
MAUDE MDR 5540256
- MDR report key
- 5540256
- Report number
- 9610617-2016-00032
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-01-22
- Date received
- 2016-03-31
- 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
- MRS. SUSIE CHEN
- Address
- 2151 E. GRAND AVENUE EL SEGUNDO CA 90245 US
- Phone
- 424-424-4242
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NASAL SCISSORS | NASAL SCISSORS | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY | KBD | 449401 | 449401 | SW | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
ALLEGEDLY, THE DOCTOR WAS PERFORMING AN ENDOSCOPIC NASAL PROCEDURE AND ONE OF THE BLADES BROKE OFF THE SCISSORS AND FELL INTO THE PATIENT. THE DOCTOR IMMEDIATELY REMOVED IT. PER THE HOSPITAL, THE PROCEDURE WAS COMPLETED AND NO INJURY TO THE PATIENT WAS REPORTED.