M-Biopsy N30120012Recalls & reported problems

Mermaid Medical A/S · Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by cutting from lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and pancreas, for microscopic examination. When used for breast biopsy, the product is for diagnosis only. · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15711055002346), received between Oct 29, 2019 and Oct 29, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Self-Activation or Keying” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

Self-Activation or Keying1

Patient problems

No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 29, 2019Self-Activation or Keying
THE M-BIOPSY SEMI-AUTOMATIC GUN HAS SELF RELEASED WHEN LOADING FOR THE THIRD BIOPSY. FURTHER INFORMATION AND THE USED PRODUCT IS ABOUT TO BE COLLECTED FROM THE CUSTOMER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9249797 ↗

Device details

UDI-DI	`15711055002346`
Brand	M-Biopsy
Model	N30120012
Company	Mermaid Medical A/S
Product code	KNW · Instrument, Biopsy
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 13, 2026

Device type (GMDN): Side-notch biopsy gun handpiece/needle

A hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.

Other Instrument, Biopsy devices

MAX-CORE MC1616
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall4,258 reports
ENCOR® ECP017G
Senorx, Inc. · INSTRUMENT, BIOPSY
1 recall4,186 reports
MAX-CORE MC1820
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall2,404 reports
MAX-CORE MC1816
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall1 death848 reports
MAX-CORE MC1410
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall399 reports
MAX-CORE MC1610
Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY
1 recall394 reports
ENCOR® ECP0110GV
Senorx, Inc. · INSTRUMENT, BIOPSY
392 reports
ENCOR® ECP0110G
Senorx, Inc. · INSTRUMENT, BIOPSY
390 reports

All Instrument, Biopsy devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page