MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-06 for HISTOCORE PELORIS 3 DUAL RETORT TISSUE PROCESSOR 45.0005 manufactured by Leica Biosystems Melbourne Pty. Ltd.
[141488251]
Although the complainant advised that 25 of the 127 biopsy tissues processed using the "biopsy run 1" protocol started in retort a at 20:01pm on (b)(6) 2019 were under-processed, the specific dimensions and specimen types were not provided by the complainant. Investigation of this complaint found that the instrument operated within specification during execution of the "biopsy run 1" protocol started in retort a at 20:01pm on (b)(6) 2019, from which sub-optimal tissue processing was identified by the complainant. No use error(s) was identified in the interaction between the user and the instrument either prior to, or during execution of the "biopsy run 1" protocol started in retort a at 20:01pm on (b)(6) 2019, from which sub-optimal tissue processing was identified by the complainant. Based on the information provided by the complainant that it was considered that the reported underprocessing of 25 of the 127 biopsy tissues was "due to them being placed on shorter than needed run", it was determined that the root cause of the sub-optimal tissue processing reported by the complainant was use of a protocol of inappropriate duration for the size of the tissue samples being processed. Section 8. 2. 1 of the leica histocore peloris 3 user manual tabulates the recommended protocol duration for maximum tissue dimensions and different specimen types.
Patient Sequence No: 1, Text Type: N, H10
[141488252]
On 05 february 2019, leica biosystems received a complaint that approximately 25 of 127 biopsy tissues were under-processed following processing. The complainant advised that no error codes had been displayed; a strong formalin odour was detected when the cassette basket was removed from the instrument; the processing run completed; the alcohol concentration had been measured manually; and reagents had been replaced two days previously. On (b)(4) 2019 a leica biosystems field support specialist (fss) visited the laboratory in order to investigate the circumstances involved in this complaint and to provide applications support. The fss documented that: "customer states that there may have been some formalin on the unit that carried the smell that the tech noted. She looked at all of the blocks impacted (25 out of the 127) and thinks that the underprocessing on those blocks is due to them being placed on shorter than needed run. She has been in contact with the pathologists and they have indicated that all of the samples look good and all of them are diagnosed". (this information was received by leica biosystems (b)(4) on (b)(4) 2019). The fss also documented that the affected biopsy tissues were derived from the "biopsy run 1" comprising 127 cassettes, which started in retort a at 19:00 on (b)(6) 2019 and completed at 21:36 on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8020030-2019-00008 |
| MDR Report Key | 8397048 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-06 |
| Date of Report | 2019-03-07 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-02-05 |
| Device Manufacturer Date | 2017-11-27 |
| Date Added to Maude | 2019-03-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS ADRIENNE HARDISTY |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, VIC 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3149 |
| Manufacturer G1 | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Street | 495 BLACKBURN ROAD |
| Manufacturer City | MOUNT WAVERLEY, VIC 3149 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 3149 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HISTOCORE PELORIS 3 DUAL RETORT TISSUE PROCESSOR |
| Generic Name | AUTOMATED TISSUE PROCESSOR |
| Product Code | IEO |
| Date Received | 2019-03-06 |
| Model Number | HISTOCORE PELORIS 3 |
| Catalog Number | 45.0005 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS MELBOURNE PTY. LTD |
| Manufacturer Address | 495 BLACKBURN ROAD MOUNT WAVERLEY, VIC 3149 AS 3149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-06 |