MONOPTY 211816Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741084751), received between Feb 27, 2024 and Jul 22, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2024Self-Activation or Keying; Failure to Obtain Sample; Self-Activation or Keying; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792438 ↗
• MalfunctionMay 25, 2024Nonstandard Device; Self-Activation or Keying; Nonstandard Device; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE WAS DESIGNED TO BE EJECTED AFTER TWO ROTATIONS FOR THE SET, BUT THE NEEDLE WAS ALLEGEDLY EJECTED ON ITS OWN ON THE SECOND ROTATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19398161 ↗
• MalfunctionFeb 27, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY PROCEDURE THROUGH NORMAL TISSUE DENSITY, WHEN THE PHYSICIAN TURNED THE GRIP TWICE TO SET IT, THE INNER NEEDLE SHOT OUT A LITTLE WHEN IT WAS SET FOR SECOND TIME AND THE DEVICE ALLEGEDLY COULD NOT ABLE TO COLLECT THE TISSUE. IT WAS FURTHER REPORTED THAT THE ARROW INDICATOR ON THE MAIN BODY WAS ALSO SET CORRECTLY AND THE PHYSICIAN INSERTED IT AND PRESSED THE FIRING BUTTON WITHOUT NOTICING THAT THE INNER NEEDLE WAS SLIGHTLY PROTRUDING AND THE TISSUE WAS ALLEGEDLY NOT COLLECTED. REPORTEDLY, THE PHYSICIAN SET IT AGAIN AND NOTICED THE PROBLEM. THE PROCEDURE COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786337 ↗
• MalfunctionFeb 27, 2024Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE PHYSICIAN TURNED THE GRIP TWICE TO SET IT, THE INNER NEEDLE ALLEGEDLY SHOT OUT A LITTLE WHEN IT WAS SET FOR SECOND TIME AND THE DEVICE ALLEGEDLY COULD NOT BE ABLE TO COLLECT TISSUE. NO COAXIAL WAS USED AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18786269 ↗