FDA Adverse Event
Injury
Summary report: N
ORIGIN
MDR report key: 259641
·
Received January 20, 2000
Report
- Report Number
- 259641
- Event Type
- Injury
- Date Received
- January 20, 2000
- Date of Event
- January 12, 2000
- Report Date
- January 19, 2000
- Manufacturer
- ORIGIN MEDISYSTEMS, INC.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CLASSIC TIP TROCAR FROM LAP HERNIA KIT BROKE WHEN IN PT. BROKEN PIECE RETRIEVED BY SURGEON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ORIGIN | TROCAR (OMS - P1 - TSS KIT) | GCJ | ORIGIN MEDISYSTEMS, INC. | 0086 | 0909991 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |