FDA Adverse Event
Injury
Summary report: N
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM
MDR report key: 830807
·
Received March 21, 2007
Report
- Report Number
- 3003515897-2007-00002
- Event Type
- Injury
- Date Received
- March 21, 2007
- Date of Event
- March 6, 2007
- Report Date
- March 21, 2007
- Manufacturer
- SANARUS MEDICAL, INC.
- Product Code
- KNW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS DISCARDED, NO ANALYSIS WILL BE PERFORMED.
Description of Event or Problem · 1
THE PHYSICIAN USED THE CASSI II ROTATIONAL CORE BIOPSY SYSTEM FOR A BREAST BIOPSY. DURING THE PROCEDURE, THE DEVICE COULD NOT PENETRATE THE LESION. THE PROCEDURE WAS DISCONTINUED AND THE PHYSICIAN RESCHEDULED THE PATIENT FOR AN OPEN SURGICAL BIOPSY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM | BIOPSY INSTRUMENT | KNW | SANARUS MEDICAL, INC. | CS2100-S | SC061204 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |