Device brand name · Instrument biopsy
Brevera Breast Biopsy System: medical device reports filed with FDA
319 reports name it, 2021–2026. Manufacturer given most often on reports: Hologic. Product code KNW.
- 319
- device reports naming the brand
- 0% of all MAUDE reports · about 65 a year
- 69
- reports, 12 months to August 2026
- 122 in the 12 months before
- 26%
- classified as malfunction
- 90.5% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
FDA's MAUDE database holds 319 reports that name the brand "Brevera Breast Biopsy System" (instrument biopsy), received between August 2021 and June 2026; the manufacturer given most often on reports is Hologic. Spellings of one product vary from report to report.
69 reports arrived in the 12 months to August 2026, down 43% from 122 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 injury (74%) and malfunction (26%); across all instrument, biopsy reports (product code KNW) death is recorded in 0.1% and malfunction in 90.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are failure to obtain sample (42%), material fragmentation (7.5%) and mechanical problem (5.6%). The patient problems coded most often are foreign body in patient, hematoma and breast discomfort/pain. 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 24,120 reports carrying product code KNW. 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 |
|---|---|---|---|
| Failure to obtain sample | 134 | 42% | 11% |
| Material fragmentation | 24 | 7.5% | 0.6% |
| Mechanical problema mechanical problem | 18 | 5.6% | 0.6% |
| Failure to fire | 14 | 4.4% | 30.2% |
| Computer software problema software problem | 8 | 2.5% | 0.1% |
| Insufficient device problem information | 6 | 1.9% | 0.3% |
| Material deformation | 4 | 1.3% | 0.2% |
| Mechanical jam | 4 | 1.3% | 0.1% |
| Breakthe device broke | 3 | 0.9% | 4.6% |
| Display or visual feedback problem | 3 | 0.9% | 0% |
| Noise, audible | 3 | 0.9% | 0.2% |
| Calibration problem | 2 | 0.6% | 0% |
| Defective devicethe device was defective | 2 | 0.6% | 0.4% |
| Infusion or flow problema problem with flow or infusion | 2 | 0.6% | 0% |
| Material split, cut or torn | 2 | 0.6% | 0% |
| Material twisted/bent | 2 | 0.6% | 1.5% |
| Suction failure | 2 | 0.6% | 0.1% |
| Application program freezes or fails to launch | 1 | 0.3% | 0% |
| Circuit failure | 1 | 0.3% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 1 | 0.3% | 0% |
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 |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 25 | 7.8% |
| Hematomaa collection of blood under the skin or in tissue | 13 | 4.1% |
| Breast discomfort/pain | 5 | 1.6% |
| Laceration(s) | 4 | 1.3% |
| Needle stick/puncture | 2 | 0.6% |
| Syncope/fainting | 2 | 0.6% |
| Altered state of consciousness | 1 | 0.3% |
| Anxietyanxiety | 1 | 0.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.3% |
| Bruise/contusion | 1 | 0.3% |
| Device embedded in tissue or plaque | 1 | 0.3% |
| Hemorrhage/blood loss/bleeding | 1 | 0.3% |
| Loss of consciousnesspassing out | 1 | 0.3% |
| Low blood pressure/ hypotension | 1 | 0.3% |
| Movement disorder | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Brevera Breast Biopsy System | Product code KNW | All MAUDE reports |
|---|---|---|---|
| Reports | 319 | 24,120 | 26,136,888 |
| Share of that pool | — | 1.3% | 0% |
| Classified as death, per 1,000 reports | 0 | 1 | 9 |
| Classified as injury | 74% | 8.3% | 36.2% |
| Classified as malfunction | 26% | 90.5% | 62.3% |
| Filed by the manufacturer | 92.2% | 94.6% | 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 KNW
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| EnCor Biopsy Probe | 5,264 | 15 | 0% |
| Maxcore | 4,025 | 1,890 | 0% |
| Bard Max-Core Disposable Core Biopsy Instrument | 2,657 | 0 | 0% |
| Bard Max-Core Disposable Biopsy Instrument | 2,335 | 0 | 0% |
| Mtome St Holster/Cables | 495 | 0 | 0% |
| Mammotome Control Module With Smartvac - 120v | 339 | 0 | 0% |
| Monopty Disposable Core Biopsy Instrument | 288 | 0 | 0% |
| Marquee | 233 | 46 | 0% |
| Asap Biopsy System | 213 | 0 | 0.5% |
| Max-Core Disposable Core Biopsy Instrument | 205 | 0 | 0% |
| Mammotome Hardware Holster | 173 | 0 | 0% |
| Achieve | 164 | 125 | 0% |
| Mammotome Control Modules | 157 | 0 | 0% |
| Radial Jaw 3 Biopsy Forceps | 302 | 0 | 0% |
| Superdimension | 227 | 5 | 7% |
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 Brevera Breast Biopsy System reports
How many FDA reports name Brevera Breast Biopsy System?
319 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 69 in the latest 12 months.
What kinds of events are reported?
injury (74%) and malfunction (26%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to obtain sample (42%), material fragmentation (7.5%), mechanical problem (5.6%), failure to fire (4.4%) and computer software problem (2.5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (92.2%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Brevera Breast Biopsy System 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.