MISSION 2020MSKRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741097102), received between Aug 18, 2021 and Nov 27, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 8, 2023Open, Classified

   The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.

   Z-0643-2024 · Root cause: Process control · FDA record ↗

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.

• InjuryNov 27, 2023Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY LUNG NODULE BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE OUTER PORTION OF THE NEEDLE ALLEGEDLY BROKE INSIDE THE PATIENT'S BODY. REPORTEDLY, A COAXIAL WAS USED. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE BROKEN PARTS FROM THE PATIENT'S BODY. THE PATIENT WAS REPORTEDLY STABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 18208128 ↗
• MalfunctionNov 8, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY STUCK AND DIFFICULT TO REMOVE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751027 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT DURING A CT GUIDED LIVER BIOPSY PROCEDURE, THE END OF THE NEEDLE ALLEGEDLY BROKE PRIOR TO REMOVAL FROM THE PATIENT. IT WAS FURTHER REPORTED THAT THE BROKEN COMPONENT WAS RETRIEVED UNDER FLUOROSCOPY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15317919 ↗
• InjuryAug 30, 2021Break; Break

  IT WAS REPORTED THAT DURING A LUNG BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY SNAPPED IN THE MIDDLE OF THE PROCEDURE AND HALF OF THE NEEDLE WAS LEFT BEHIND IN THE PATIENT. IT WAS FURTHER REPORTED THAT ADDITIONAL SURGERY WAS DONE TO REMOVE THE NEEDLE. A COAXIAL NEEDLE WAS USED IN THE PROCEDURE AND THE PATIENT WAS REPORTED TO BE IN A STABLE CONDITION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12381780 ↗
• InjuryAug 18, 2021Break; Entrapment of Device

  DURING CT GUIDED BIOPSY OF LUNG, BIOPSY NEEDED BROKE ON RETRIEVAL RESULTING IN 12CM OF NEEDLE BEING RETAINED AND REQUIRING SURGERY TO REMOVE. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12342687 ↗