Device brand name · Core biopsy system
Asap Biopsy System: medical device reports filed with FDA
213 reports name it, 1997–2002. Manufacturer given most often on reports: Medi-Tech/A Division Of Boston Scientific. Product code KNW.
- 213
- device reports naming the brand
- 0% of all MAUDE reports · about 7 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 93%
- classified as malfunction
- 90.5% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
FDA's MAUDE database holds 213 reports that name the brand "Asap Biopsy System" (core biopsy system), received between September 1997 and August 2002; the manufacturer given most often on reports is Medi-Tech/A Division Of Boston Scientific. 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 (93%), injury (6.6%) and death (0.5%); 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 replace (85.9%), sharp/jagged/rough/etched/scratched (55.9%) and bent (22.5%). The patient problems coded most often are bleeding, hospitalization required and hematoma. 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 Asap Biopsy System was received in the five years to August 2026; the latest was received in August 2002.
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 |
|---|---|---|---|
| Replace | 183 | 85.9% | 3.4% |
| Sharp/jagged/rough/etched/scratched | 119 | 55.9% | 0.5% |
| Bent | 48 | 22.5% | 0.8% |
| Difficult to insertthe device was hard to insert | 43 | 20.2% | 0.5% |
| Other (for use when an appropriate device code cannot be identified) | 41 | 19.2% | 0.8% |
| Difficult to removethe device was hard to remove | 19 | 8.9% | 3.5% |
| Failure to advance | 17 | 8% | 0.2% |
| Defective devicethe device was defective | 5 | 2.3% | 0.4% |
| Foreign material | 5 | 2.3% | 0.1% |
| Design/structure problem | 3 | 1.4% | 0% |
| Material frayed | 3 | 1.4% | 0.1% |
| Detachment of device component | 2 | 0.9% | 1% |
| Improper or incorrect procedure or method | 2 | 0.9% | 0.2% |
| Retraction problem | 2 | 0.9% | 0.2% |
| Defective component | 1 | 0.5% | 0.2% |
| Device issuea problem with the device | 1 | 0.5% | 1% |
| Device, or device fragments remain in patient | 1 | 0.5% | 0.8% |
| Difficult or delayed positioning | 1 | 0.5% | 0% |
| Excess flow or over-infusion | 1 | 0.5% | 0% |
| Failure to fire | 1 | 0.5% | 30.2% |
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 |
|---|---|---|
| Bleeding | 6 | 2.8% |
| Hospitalization required | 6 | 2.8% |
| Hematomaa collection of blood under the skin or in tissue | 5 | 2.3% |
| Painpain, site not specified | 4 | 1.9% |
| Therapy/non-surgical treatment, additional | 4 | 1.9% |
| Dural tear | 3 | 1.4% |
| Surgical procedure | 2 | 0.9% |
| Surgical procedure, additional | 2 | 0.9% |
| Tissue damage | 2 | 0.9% |
| Device induced | 1 | 0.5% |
| Foreign body, removal of | 1 | 0.5% |
| Hematuria | 1 | 0.5% |
| Nonresorbable materials, unretrieved in body | 1 | 0.5% |
| Other (for use when an appropriate patient code cannot be identified) | 1 | 0.5% |
| Surgical procedure, repeated | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Asap Biopsy System | Product code KNW | All MAUDE reports |
|---|---|---|---|
| Reports | 213 | 24,120 | 26,136,888 |
| Share of that pool | — | 0.9% | 0% |
| Classified as death, per 1,000 reports | 5 | 1 | 9 |
| Classified as injury | 6.6% | 8.3% | 36.2% |
| Classified as malfunction | 93% | 90.5% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Brevera Breast Biopsy System | 319 | 69 | 0% |
| Monopty Disposable Core Biopsy Instrument | 288 | 0 | 0% |
| Marquee | 233 | 46 | 0% |
| 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 Asap Biopsy System reports
How many FDA reports name Asap Biopsy System?
213 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 (93%), injury (6.6%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
replace (85.9%), sharp/jagged/rough/etched/scratched (55.9%), bent (22.5%), difficult to insert (20.2%) and other (for use when an appropriate device code cannot be identified) (19.2%). 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 Asap 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.