Devices › Processor, tissue, automated
Device brand name · Automated tissue processor
Peloris Rapid Tissue Processor: medical device reports filed with FDA
933 reports name it, 2008–2021. Manufacturer given most often on reports: Leica Biosystems Melbourne. Product code IEO.
- 933
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 53.1%
- classified as malfunction
- 48.3% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 933 reports that name the brand "Peloris Rapid Tissue Processor" (automated tissue processor), received between January 2008 and December 2021; the manufacturer given most often on reports is Leica Biosystems Melbourne. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (53.1%), injury (44.6%) and other (0.3%); across all processor, tissue, automated reports (product code IEO) death is recorded in 0% and malfunction in 48.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are improper or incorrect procedure or method (30%), device operates differently than expected (17.3%) and product quality problem (6.9%). The patient problems coded most often are tissue damage, injury and surgical procedure. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,658 reports carrying product code IEO. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Improper or incorrect procedure or method | 280 | 30% | 42.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 161 | 17.3% | 11.6% |
| Product quality problem | 64 | 6.9% | 4.3% |
| Device displays incorrect message | 30 | 3.2% | 2.5% |
| Insufficient device problem information | 24 | 2.6% | 4.7% |
| Failure to obtain sample | 18 | 1.9% | 1.4% |
| Device emits odor | 7 | 0.8% | 0.5% |
| Incorrect or inadequate test results | 7 | 0.8% | 0.2% |
| Device ingredient or reagent problem | 6 | 0.6% | 0.7% |
| Failure to cut | 6 | 0.6% | 0.4% |
| Mechanical problema mechanical problem | 6 | 0.6% | 0.4% |
| Nonstandard device | 6 | 0.6% | 0.4% |
| Output below specifications | 6 | 0.6% | 0.4% |
| Fluid/blood leak | 5 | 0.5% | 0.2% |
| Application program problem: parameter calculation error | 4 | 0.4% | 0.4% |
| Leak/splashthe device leaked | 4 | 0.4% | 1.1% |
| Contamination of device ingredient or reagent | 3 | 0.3% | 0.4% |
| Device contamination with chemical or other material | 3 | 0.3% | 0.1% |
| Device operational issue | 3 | 0.3% | 0.2% |
| Programming issue | 3 | 0.3% | 0.3% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Tissue damage | 115 | 12.3% |
| Injurya physical injury | 91 | 9.8% |
| Surgical procedure | 6 | 0.6% |
| Complaint, ill-defined | 4 | 0.4% |
| Misdiagnosis | 3 | 0.3% |
| Chemical exposure | 2 | 0.2% |
| Test result | 2 | 0.2% |
| Asthmaasthma | 1 | 0.1% |
| Atrial fibrillationan irregular heart rhythm | 1 | 0.1% |
| Bruise/contusion | 1 | 0.1% |
| Crushing injury | 1 | 0.1% |
| Electric shockan electric shock | 1 | 0.1% |
| Eye injury | 1 | 0.1% |
| Laceration(s) | 1 | 0.1% |
| Missing value reason | 1 | 0.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Peloris Rapid Tissue Processor | Product code IEO | All MAUDE reports |
|---|---|---|---|
| Reports | 933 | 1,658 | 26,136,888 |
| Share of that pool | — | 56.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 44.6% | 49.9% | 36.2% |
| Classified as malfunction | 53.1% | 48.3% | 62.3% |
| Filed by the manufacturer | 88.2% | 83.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Questions about Peloris Rapid Tissue Processor reports
How many FDA reports name Peloris Rapid Tissue Processor?
933 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (53.1%), injury (44.6%) and other (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
improper or incorrect procedure or method (30%), device operates differently than expected (17.3%), product quality problem (6.9%), device displays incorrect message (3.2%) and insufficient device problem information (2.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (88.2%), distributor reports (11.5%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Peloris Rapid Tissue Processor was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.