MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-11-17 for IP BIOPSY CASSETTE II 38440500 manufactured by Leica B Iosystems Richmond.
[2464205]
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.
Patient Sequence No: 1, Text Type: D, B5
[9558806]
The affected tissue processing cassette was not returned to continue investigation. There have been no other reported incidents with this product of this nature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1419341-2011-00001 |
| MDR Report Key | 2372035 |
| Report Source | 00 |
| Date Received | 2011-11-17 |
| Date of Report | 2011-10-27 |
| Date of Event | 2011-08-05 |
| Date Mfgr Received | 2011-10-27 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2012-07-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT |
| Manufacturer Street | 5205 US ROUTE 12 |
| Manufacturer City | RICHMOND IL 60071 |
| Manufacturer Country | US |
| Manufacturer Postal | 60071 |
| Manufacturer Phone | 8156782000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IP BIOPSY CASSETTE II |
| Generic Name | TISSUE CASSETTE |
| Product Code | KER |
| Date Received | 2011-11-17 |
| Model Number | 38440500 |
| Catalog Number | 38440500 |
| Lot Number | 130205369 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA B IOSYSTEMS RICHMOND |
| Manufacturer Address | 5205 US RT 12 RICHMOND IL 60071 US 60071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-17 |