N
Patient 1
THE ELECTRODE HAS NOT BEEN RETURNED FOR EVALUATION.
MAUDE MDR 8259001
- MDR report key
- 8259001
- Report number
- 9610617-2019-00012
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-11-14
- Date received
- 2019-01-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. SUSIE CHEN
- Address
- 2151 EAST GRAND AVENUE EL SEGUNDO CA 90245 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BIPOLAR CUTTING LOOP | BIPOLAR CUTTING LOOP | KARL STORZ SE & CO. KG | HIN | 26040GP1 | 26040GP1 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-01-17 | 0 | 1. R |
Event Narratives#
D
Patient 1
ALLEGEDLY, DURING A HYSTEROSCOPIC MYOMECTOMY PROCEDURE, THE BIPOLAR ELECTRODE LOOP BROKE AND THE DOCTOR REQUESTED THE MYOSURE TISSUE REMOVAL SYSTEM AND SUBSEQUENTLY FOUND A SMALL PIECE OF LOOP FROM THE ELECTRODE INSIDE THE MYOSURE TISSUE REMOVAL SYSTEM. THEY CONFIRMED ALL PIECES HAD BEEN REMOVED AND THERE WAS NO PATIENT HARM.