SuperCore™ Biopsy Instrument 701118090Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00886333005895), received between Jul 16, 2020 and Dec 2, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE PLEURA BIOPSY PROCEDURE, THE INTERVENTIONAL DOCTOR PRICKS THE LITTLE FINGER OF HIS RIGHT HAND WHEN THE NEEDLE IS DISASSEMBLED DURING THE PROCEDURE, CAUSING A BIOLOGICAL ACCIDENT."

  Patient problems: Needle Stick/Puncture

  MAUDE report 18253199 ↗
• MalfunctionJan 31, 2023Break; Break

  DOCTOR INDICATES THAT THE HANDLE SEPARATES FORM THE NEEDLE ASSEMBLY WITH MINIMAL EFFORT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271747 ↗
• MalfunctionOct 19, 2021Break; Nonstandard Device

  THE SUPERCORE NEEDLE FELL APART DURING USE. THE DOCTOR STABBED HIS HAND WITH THE BROKEN DEVICE, LEFT HAND, LITTLE FINGER. NO INJURY TO PATIENT.

  Patient problems: Needle Stick/Puncture

  MAUDE report 12661472 ↗
• MalfunctionAug 18, 2021Break

  SUPERCORE NEEDLES X 4 AFFECTED. 3 X NEEDLES SO FAR HAVE ¿BROKEN APART¿ UPON TESTING. 1 X NEEDLE DID NOT FALL APART ON TESTING, BUT THEN BROKE APART WHEN INSIDE PATIENT. DR HAD TO RETRIEVE BROKEN NEEDLE FROM PATIENT. PATIENT NOT INJURED. FACILITY HAVE TAKEN 2 X BOXES OF THE SAME LOT NUMBER OFF THE SHELF. PLEASE SEE REPORT FORM DR. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12339619 ↗
• MalfunctionJul 16, 2020Break; Physical Resistance/Sticking

  THE PROCEDURE WAS AN ULTRASOUND BIOPSY, A CO-AXIAL 3.9CM INTRODUCER WAS INSERTED UNDER ANAESTHETIC AND THEN THE BIOPSY DEVICE PASSED THROUGH THE MIDDLE. THIS ENCOUNTERED A LOT OF RESISTANCE, ALTHOUGH THE PATIENT DID NOT FLINCH AT THIS. A SCANTY TISSUE SPECIMEN WAS RECOVERED AND THEN THE BIOPSY NEEDLE WAS RE- POSITIONED AND PLACED INTO THE INTRODUCER. ON THE SECOND PASS DR. TAYLOR EXPERIENCED RESISTANCE BOTH ON FIRING THE NEEDLE AND WITHDRAWING THIS THROUGH THE INTRODUCER. A GOOD TISSUE SAMPLE WAS DELIVERED, BUT ALSO A V- SHAPED SILVER OF METAL WHICH APPEARED TO HAVE BEEN SHEARED OFF THE SPECIMEN NOTCH. A SECOND IDENTICAL NEEDLE WAS THEREFORE USED TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER PROBLEMS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10286863 ↗