SuperCore™ Biopsy Instrument 701218200Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00886333006052), received between Mar 15, 2022 and Aug 29, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Firing Problem” (2 reports).

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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2022Break; Nonstandard Device; Firing Problem

  NEEDLE INSERTED INTO PATIENT. BROKE APART UPON FIRING TO RETRIEVE SAMPLE.

  Patient problems: Insufficient Information

  MAUDE report 15313973 ↗
• MalfunctionMar 15, 2022Firing Problem; Physical Resistance/Sticking

  THE DOCTOR WROTE; THE PISTOL FIRED TWICE WITHOUT ME PRESSING HARD OR ALL THE WAY IN. AT 2 BIOPSIES, I HAD DIFFICULTY PULLING UP THE BIOPSY NEEDLE VIA THE COAXIAL. HAD TO USE FORCE. ON THE WAY UP, I FELT THAT SOMETHING WAS SCRATCHING THE COAXIAL ALL THE WAY UP. FINALLY, WHEN I OPENED THE SLEEVE, I SAW THAT THERE WAS A WIRE-LIKE BODY IN THE SLEEVE ALONG WITH THE BIOPSY. THIS ONE FELT LIKE METALLIC. UNFORTUNATELY, I DID NOT TAKE CARE OF THE FOREIGN BODY BUT ONLY THE BIOPSY NEEDLE. /COAXIAL NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13768111 ↗