FDA Adverse Event
Other
Summary report: N
BIOPSYS - MICROMARK II
MDR report key: 273265
·
Received April 6, 2000
Report
- Report Number
- 273265
- Event Type
- Other
- Date Received
- April 6, 2000
- Date of Event
- March 28, 2000
- Report Date
- March 28, 2000
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- KNW
- Report Source
- User Facility report
- Reporter Location
- SD, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING ROUTINE STEREOTACTIC RIGHT BREAST BIOPSY, TISSUE MARKER DEPLOYED PER STANDARD PROCEDURE. INITIAL CLIP NOT VISUALIZED ON FILMS SO PROCEDURE REPEATED. UPON COMPLETION, NOTED THE NORMAL SMALL CLIP WAS INSIDE A LARGER METAL PIECE THAT ORIGINALLY HOUSED THE CLIP. SECOND GROUP OF CALCIFICATIONS NOT BIOPSIED AT THIS TIME. DR RECOMMENDED LOCALIZATION PROCEDURE FOR THEM AND REMOVAL OF METAL HOUSING AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPSYS - MICROMARK II | TISSUE MARKER - MAMMOTOME | KNW | ETHICON ENDO-SURGERY, INC. | C1535 (REF) | N4GC81 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other | FOR 4/12/00 AT 9:00 AM.| LOCAL ANESTHETIC AND SURGICAL REMOVAL SCHEDULED |