MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-10 for PELORIS RAPID TISSUE PROCESSOR 26.0005 manufactured by Leica Biosystems Melbourne Pty. Ltd.
[179812564]
Leica biosystems received a tissue processing complaint of "brittle tissue," which occurred on (b)(6) 2019. The complainant advised that 11 out of 58 cases have not been able to be diagnosed. On 03 december 2019, leica biosystems received the following information in relation to the event on (b)(6) 2019: "there are eleven (11) cases that could potentially have repeat biopsies. Currently, there have been two repeat biopsy cases: (b)(6) y. O. /female/vaginal bx and (b)(6) y. O. /female/endometrial bx. All cases able to be diagnosed? : no, 11 of 58 cases cannot be diagnosed. " the following information was received in relation to the event on (b)(6) 2019: "currently, there have not been any repeat biopsy cases. There is one (1) cases that could potentially have a repeat procedure. All cases able to be diagnosed? No, one case cannot be diagnosed by pathology but was diagnosed by radiology. " as of 10 january 2020, leica biosystems has not received any further information in relation to the other undiagnosable cases. Refer to importer report #: 1423337-2020-00002 for specific details on the other patient involved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423337-2020-00001 |
| MDR Report Key | 9576070 |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-11-08 |
| Date Facility Aware | 2019-11-26 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-01-10 |
| Date Added to Maude | 2020-01-10 |
| 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 | 2020-01-10 |
| Model Number | PELORIS |
| Catalog Number | 26.0005 |
| 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 | 2020-01-10 |