FDA Adverse Event
Malfunction
Summary report: N
KOS - RAPID MICROWAVE HISTOPROCESSOR
MDR report key: 2315430
·
Received October 11, 2011
Report
- Report Number
- 1000391282-2011-00002
- Event Type
- Malfunction
- Date Received
- October 11, 2011
- Date of Event
- September 7, 2011
- Report Date
- October 6, 2011
- Manufacturer
- MILESTONE S.R.L.
- Product Code
- KPA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
DURING THE STANDARD USE OF THE UNIT, WHILE IN THE PARAFFIN-WAX STEP, PARAFFIN HEATED TO A TEMPERATURE THAT MELTED THE FORTY-FIVE CASSETTES. AS A CONSEQUENCE, THE BIOPSY TISSUE INSIDE THE CASSETTES WERE DAMAGED AND A SATISFACTORY DIAGNOSIS WAS NOT POSSIBLE. THE UNIT WAS OPERATING ON A POWER SUPPLY SOURCE AND GROUND CONDITION NOT ADEQUATE BASED ON THE PROVIDED POWER REQUIREMENTS DESIGNATED ON THE PRE-INSTALLATION GUIDE AND USER MANUAL PROVIDED TO THE USER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KOS - RAPID MICROWAVE HISTOPROCESSOR | PROCESSOR, TISSUE, AUTOMATED | KPA | MILESTONE S.R.L. | KOS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |