Quick-Core G28292Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002282926), received between Sep 28, 2017 and Oct 5, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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.

• MalfunctionOct 5, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  THE INTERNATIONAL CUSTOMER REPORTED THAT, AFTER THE BEGINNING OF THE PROCEDURE BUT PRIOR TO PATIENT CONTACT, THE DEVICE OPERATOR WAS RINSING THE QUICK-CORE COAXIAL BIOPSY NEEDLE WHEN "THE MECHANISM ENGAGED SUDDENLY CAUSING THE BREAKING" [SIC]. THE OPERATOR WAS NOT ABLE TO USE THE PRODUCT, AND SO IT WAS DISCARDED AND ANOTHER NEEDLE FROM A DIFFERENT LOT WAS EMPLOYED TO COMPLETE THE PROCEDURE. NO FURTHER COMPLICATIONS WERE REPORTED, AND THE PATIENT IS REPORTEDLY FINE. THE CUSTOMER REPORTED THAT THE PRODUCT IS AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RECEIVED. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PROCEDURE AT THE TIME OF THE EVENT WAS A LUNG BIOPSY PROCEDURE. ALSO, ACCORDING TO THE CUSTOMER, "THE NEEDLE WAS STILL USED BUT THE RADIOLOGIST HAD A LOT OF PROBLEM WHEN USING IT. THE PATIENT WAS UNCOMFORTABLE FOR SURE AND THE RADIOLOGIST WAS NOT SATISFIED". THE NEEDLE WAS THROWN AWAY IN THE GARBAGE AND ANOTHER FROM A DIFFERENT LOT WAS USED. THE PHYSICIAN WHO REGULARLY USES THE PRODUCT, SAID IT WAS NOT AS SHARP AS USUAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6916982 ↗
• MalfunctionSep 28, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, ON (B)(6) 2017, WHEN THE SURGEON WAS RINSING A QUICK-CORE COAXIAL BIOPSY NEEDLE, THE DEVICE ENGAGED SUDDENLY, AND RESULTED IN THE BREAKAGE OF THE DEVICE. THE SURGEON WAS NOT ABLE TO REUSE THE PRODUCT, SO IT WAS THROWN IN THE TRASH, AND ANOTHER PRODUCT FROM A DIFFERENT LOT WHICH WAS IN THE CUSTOMER'S INVENTORY WAS EMPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTEDLY FINE, AND THE CUSTOMER CONFIRMED THAT NO PART OF THE DEVICE WAS LEFT INSIDE THE PATIENT. THE BIOPSY WAS REPORTEDLY COMPLETED SAFELY AND NO PATIENT ADVERSE EVENTS WERE EXPERIENCED. THE RADIOLOGIST FELT THE PATIENT WAS UNCOMFORTABLE AND WAS NOT SATISFIED WITH THE NEEDLE. ANOTHER PHYSICIAN STATED THE NEEDLE WAS NOT AS SHARP AS USUAL. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE COMPLAINT PRODUCT WERE NOT REPORTED. THE PRODUCT IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER, AS OF THE DATE OF THIS REPORT, NO PRODUCT HAS YET BEEN RETURNED FOR INVESTIGATION.

  Patient problems: Pain

  MAUDE report 6901915 ↗