FDA Adverse Event
Malfunction
Summary report: N
PELORIS RAPID TISSUE PROCESSOR
MDR report key: 2070561
·
Received April 8, 2011
Report
- Report Number
- 8020030-2011-00023
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 9, 2011
- Manufacturer
- LEICA BIOSYSTEMS MELBOURNE
- Product Code
- IEO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION OF THIS COMPLAINT BY LEICA MICROSYSTEMS IS CONTINUING.
Description of Event or Problem · 1
ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM PROTOCOLS RUN OVER A NUMBER OF DAYS, COMMENCING ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). AT THE TIME OF NOTIFYING LEICA MICROSYSTEMS OF THIS COMPLAINT, THE INITIAL REPORTER ADVISED THAT ALL THE TISSUE SAMPLES EXHIBITING SUB-OPTIMAL PROCESSING WERE ABLE TO BE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PELORIS RAPID TISSUE PROCESSOR | TISSUE PROCESSOR | IEO | LEICA BIOSYSTEMS MELBOURNE | PELORIS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |