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FDA product code KNW · class 2 · Gastroenterology, Urology
Instrument, biopsy: medical device reports filed with FDA
24,120 reports carry this product code, 1994–2026; 30 brands with a page.
- 24,120
- reports with this product code
- 0.1% of all MAUDE reports
- 2,826
- reports, 12 months to August 2026
- 1,457 in the 12 months before
- 90.5%
- classified as malfunction
- 62.3% across all reports
- 0.1%
- classified as death, as reported
- 0.9% across all reports
Product code KNW is FDA's classification for "Instrument, biopsy" (gastroenterology, Urology panel), a class 2 device. 24,120 medical device reports carry this product code, 0.1% of the MAUDE database, from May 1994 to August 2026.
2,826 reports arrived in the 12 months to August 2026, up 94% from 1,457 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 (90.5%), injury (8.3%) and other (0.8%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Bard Peripheral Vascular | 16,854 | 69.9% |
| Hologic | 1,131 | 4.7% |
| Ethicon Endo-Surgery Cincinnati | 967 | 4% |
| Ethicon Endo Surgery Cincinnati | 765 | 3.2% |
| Ethicon Endo-Surgery | 514 | 2.1% |
| Argon Medical Devices | 485 | 2% |
| Merit Medical Systems | 262 | 1.1% |
| Allegiance Healthcare | 151 | 0.6% |
| Carefusion | 105 | 0.4% |
| Cardinal Health | 80 | 0.3% |
| Ethicon Endo Surgery | 66 | 0.3% |
| Medtronic Advanced Energy | 63 | 0.3% |
| Boston Scientific | 30 | 0.1% |
| Cook | 19 | 0.1% |
| Covidien - Superdimension | 19 | 0.1% |
Reports by month, five years
FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
Event type and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to fire | 7,290 | 30.2% |
| Suction problem | 4,480 | 18.6% |
| Failure to obtain sample | 2,649 | 11% |
| Self-activation or keying | 1,982 | 8.2% |
| Breakthe device broke | 1,116 | 4.6% |
| Failure to prime | 902 | 3.7% |
| Difficult to removethe device was hard to remove | 851 | 3.5% |
| Replace | 827 | 3.4% |
| Device displays incorrect message | 759 | 3.1% |
| Nonstandard device | 374 | 1.6% |
| Device contamination with chemical or other material | 353 | 1.5% |
| Material twisted/bent | 350 | 1.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 302 | 1.3% |
| Detachment of device or device componentpart of the device came off | 249 | 1% |
| Detachment of device component | 240 | 1% |
| Device issuea problem with the device | 235 | 1% |
| Leak/splashthe device leaked | 229 | 0.9% |
| Tear, rip or hole in device packaging | 223 | 0.9% |
| Component(s), broken | 219 | 0.9% |
| Bent | 203 | 0.8% |
Questions about instrument, biopsy reports
What is product code KNW?
FDA's classification code for "Instrument, biopsy", class 2, reviewed by the gastroenterology, Urology panel. Every device report carries the product code of the device involved.
How many reports carry this code?
24,120 reports through August 2026, 2,826 of them in the latest 12 months.
Which brands appear most often?
EnCor Biopsy Probe (5,257), Maxcore (4,025), Bard Max-Core Disposable Core Biopsy Instrument (2,657), Bard Max-Core Disposable Biopsy Instrument (2,335) and Mtome St Holster/Cables (495). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.