FDA Adverse Event
Malfunction
Summary report: N
PELORIS RAPID TISSUE PROCESSOR
MDR report key: 2070546
·
Received April 13, 2011
Report
- Report Number
- 8020030-2011-00024
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 14, 2011
- Manufacturer
- LEICA BIOSYSTEMS MELBOURNE
- Product Code
- IEO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 ENDOCHOICE REGARDING SUB-OPTIMAL TISSUE PROCESSING FROM A NUMBER OF PROTOCOLS COMMENCED ON (B)(6) 2011, USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED INFORMATION THAT ALL THE TISSUE SAMPLES FROM THE PROTOCOLS FOR WHICH SUB-OPTIMAL TISSUE PROCESSING WAS IDENTIFIED 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 |