FDA Adverse Event
Malfunction
Summary report: N
IP BIOPSY CASSETTE II
MDR report key: 2372035
·
Received November 17, 2011
Report
- Report Number
- 1419341-2011-00001
- Event Type
- Malfunction
- Date Received
- November 17, 2011
- Date of Event
- August 5, 2011
- Report Date
- October 27, 2011
- Manufacturer
- LEICA B IOSYSTEMS RICHMOND
- Product Code
- KER
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE AFFECTED TISSUE PROCESSING CASSETTE WAS NOT RETURNED TO CONTINUE INVESTIGATION. THERE HAVE BEEN NO OTHER REPORTED INCIDENTS WITH THIS PRODUCT OF THIS NATURE.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT AFTER PROCESSING, A TISSUE CASSETTE WAS MISSING A PIECE AND THE TISSUE WAS FOUND AT THE BOTTOM OF THE PROCESSOR. NO RE-BIOPSY OF THE PATIENT WAS REQUIRED AND THIS EVENT DID NOT AFFECT THE DIAGNOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IP BIOPSY CASSETTE II | TISSUE CASSETTE | KER | LEICA B IOSYSTEMS RICHMOND | 38440500 | 130205369 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |