Type of Device | PROCESSOR, TISSUE, AUTOMATED |
Manufacturer (Section D) |
LEICA BIOSYSTEMS NUSSLOCH GMBH |
heidelbergerstrasse 17-19 |
nussloch 69226 |
GM 69226 |
|
Manufacturer (Section G) |
LEICA MICROSYSTEMS LTD. SHANGHAI |
building 1, 258 jinzang road |
|
shanghai,pudong 20120 6 |
CH
201206
|
|
Manufacturer Contact |
robert
gropp
|
heidelbergerstrasse 17-19 |
nussloch 69226
|
GM
69226
|
6224143345
|
|
MDR Report Key | 19123912 |
MDR Text Key | 340351695 |
Report Number | 8010478-2024-00010 |
Device Sequence Number | 1 |
Product Code |
IEO
|
UDI-Device Identifier | 04049188217769 |
UDI-Public | (01)04049188217769(11)220808 |
Combination Product (y/n) | N |
Reporter Country Code | SP |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
04/17/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | HISTOCORE PEGASUS PLUS |
Device Catalogue Number | 14048858007 |
Distributor Facility Aware Date | 03/18/2024 |
Initial Date Manufacturer Received |
03/18/2024
|
Initial Date FDA Received | 04/17/2024 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/08/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |