FDA Adverse Event
Malfunction
Summary report: N
OLYMPUS
MDR report key: 285433
·
Received July 7, 2000
Report
- Report Number
- 285433
- Event Type
- Malfunction
- Date Received
- July 7, 2000
- Date of Event
- June 2, 2000
- Report Date
- June 6, 2000
- Manufacturer
- *
- Product Code
- HCZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
DURING A HYSTERECTEROSCOPY, WHILE ATTEMPTING TO REMOVE AN INTRAUTERINE DEVICE, THE JAWS OF THE GRASPER BROKE. HALF OF THE JAW WAS RETRIEVED AND HALF WAS NOT. PHYSICIAN MADE AWARE OF SITUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS | GRASPER A4695 | HCZ | * | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |