MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for PELORIS RAPID TISSUE PROCESSOR PELORIS II 26.0008 manufactured by Leica Biosystems Melbourne Pty. Ltd.
[178608091]
Leica biosystems received a complaint of under processed tissue following completion of processing. On 21 january 2020, leica biosystems received information that not all cases involved in this event were diagnosable; re-biopsy has been recommended. Of the 96 blocks involved, the number needing re-biopsy is currently unknown and re-biopsy has not been performed. Information as to the final status of the tissue samples and the patient outcome has not been provided as of 30 january 2020. If additional information is obtained a follow up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2020-00003 |
| MDR Report Key | 9648794 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-21 |
| Date Facility Aware | 2020-01-21 |
| Report Date | 2020-01-30 |
| Date Reported to FDA | 2020-01-30 |
| Date Reported to Mfgr | 2020-01-30 |
| Date Added to Maude | 2020-01-30 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PELORIS RAPID TISSUE PROCESSOR |
| Generic Name | AUTOMATED TISSUE PROCESSOR |
| Product Code | IEO |
| Date Received | 2020-01-30 |
| Model Number | PELORIS II |
| Catalog Number | 26.0008 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Address | 495 BLACKBURN ROAD MOUNT WAVERLEY, 3149 AS 3149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-30 |