Devices › Indicator, biological sterilization process
Device brand name · Indicator biological
Cyclesure Biological Indicator: medical device reports filed with FDA
263 reports name it, 2005–2011. Manufacturer given most often on reports: Advanced Sterilization Products. Product code FRC.
- 263
- device reports naming the brand
- 0% of all MAUDE reports · about 13 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 97%
- classified as malfunction
- 91.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
263 medical device reports received by FDA name the brand "Cyclesure Biological Indicator" (indicator biological); the manufacturer given most often on reports is Advanced Sterilization Products; received from September 2005 to January 2011. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
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 (97%) and injury (3%); across all indicator, biological sterilization process reports (product code FRC) death is recorded in 0% and malfunction in 91.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are other (for use when an appropriate device code cannot be identified) (67.7%), chemical problem (1.5%) and false positive result (1.5%). The patient problems coded most often are skin discoloration, burning sensation and burn(s). 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
No report naming Cyclesure Biological Indicator was received in the five years to August 2026; the latest was received in January 2011.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,469 reports carrying product code FRC. 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 |
|---|---|---|---|
| Other (for use when an appropriate device code cannot be identified) | 178 | 67.7% | 12.7% |
| Chemical problem | 4 | 1.5% | 20.9% |
| False positive result | 4 | 1.5% | 0.8% |
| Improper or incorrect procedure or method | 4 | 1.5% | 1.2% |
| Breakthe device broke | 3 | 1.1% | 0.9% |
| Leak/splashthe device leaked | 3 | 1.1% | 0.7% |
| Microbial contamination of device | 3 | 1.1% | 0.3% |
| Application interface becomes non-functional or program exits abnormally | 2 | 0.8% | 0.1% |
| Device disinfection or sterilization issue | 2 | 0.8% | 0.5% |
| Fluid/blood leak | 2 | 0.8% | 0.3% |
| Improper chemical reaction | 2 | 0.8% | 0.2% |
| Incorrect, inadequate or imprecise result or readings | 2 | 0.8% | 0.5% |
| Burst container or vessel | 1 | 0.4% | 0.1% |
| Contamination | 1 | 0.4% | 0.1% |
| Contamination /decontamination problem | 1 | 0.4% | 0.5% |
| Crackthe device cracked | 1 | 0.4% | 0.1% |
| Detachment of device component | 1 | 0.4% | 0.1% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.4% | 0.2% |
| Device issuea problem with the device | 1 | 0.4% | 0.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.4% | 12.3% |
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 |
|---|---|---|
| Skin discoloration | 31 | 11.8% |
| Burning sensationa burning feeling | 19 | 7.2% |
| Burn(s)a burn | 14 | 5.3% |
| Cut(s) | 11 | 4.2% |
| Therapy/non-surgical treatment, additional | 8 | 3% |
| Chemical exposure | 4 | 1.5% |
| Tingling | 4 | 1.5% |
| Exposure to body fluids | 3 | 1.1% |
| Improved patient condition | 3 | 1.1% |
| No patient involvement | 3 | 1.1% |
| Other (for use when an appropriate patient code cannot be identified) | 3 | 1.1% |
| Itching sensation | 2 | 0.8% |
| Laceration(s) | 2 | 0.8% |
| Bleeding | 1 | 0.4% |
| Crushing injury | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Cyclesure Biological Indicator | Product code FRC | All MAUDE reports |
|---|---|---|---|
| Reports | 263 | 1,469 | 26,136,888 |
| Share of that pool | — | 17.9% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 3% | 1.6% | 36.2% |
| Classified as malfunction | 97% | 91.6% | 62.3% |
| Filed by the manufacturer | 100% | 95.8% | 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."
Other brands with product code FRC
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Sterrad Cyclesure 24 Biological Indicator | 890 | 0 | 0% |
| Stryker | 559 | 5 | 1.3% |
| Genesis | 1,648 | 0 | 0.1% |
| Verify | 2,413 | 8 | 0% |
| Sterrad Nx Sterilizer | 1,006 | 0 | 0% |
| Sterrad 100s Sterilizer | 1,162 | 0 | 0% |
Ordered by report count for navigation only. 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 also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Cyclesure Biological Indicator reports
How many FDA reports name Cyclesure Biological Indicator?
263 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 (97%) and injury (3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
other (for use when an appropriate device code cannot be identified) (67.7%), chemical problem (1.5%), false positive result (1.5%), improper or incorrect procedure or method (1.5%) and break (1.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Cyclesure Biological Indicator 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.