MONOPTY 211610Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741084713), received between Jun 5, 2017 and Apr 13, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2024Nonstandard Device; Self-Activation or Keying; Nonstandard Device; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BREAST BIOPSY PROCEDURE, WHEN THE GREEN GRIP WAS TURNED TWICE FOR SETTING, THE OUTER CYLINDER OF THE DEVICE ALLEGEDLY FIRED ON ITS OWN. A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102705 ↗
• MalfunctionApr 3, 2024Failure to Prime; Self-Activation or Keying; Failure to Fire; Failure to Prime; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE PRIMED AND IT SUDDENLY FIRED. IT WAS FURTHER REPORTED THAT, AFTER THE DEVICE WAS PRIMED SUCCESSFULLY, BUT THE DEVICE ALLEGEDLY FAILED TO FIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19030494 ↗
• MalfunctionDec 5, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED ON ITS OWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272005 ↗
• MalfunctionDec 5, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ECHO GUIDED BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FIRED ON ITS OWN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18271980 ↗
• MalfunctionNov 14, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY FIRED WITHOUT PRESSING THE FIRING BUTTON. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129729 ↗
• MalfunctionOct 26, 2023Failure to Prime; Self-Activation or Keying; Failure to Fire; Failure to Prime; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO BE PRIMED AND IT SUDDENLY FIRED. IT WAS FURTHER REPORTED THAT, AFTER THE DEVICE WAS PRIMED SUCCESSFULLY, BUT THE DEVICE ALLEGEDLY FAILED TO FIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010983 ↗
• MalfunctionSep 21, 2021Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING A BREAST BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO FIRE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12507195 ↗
• MalfunctionOct 22, 2020Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL 211610 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED SELF-ACTIVATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION WAS INVOLVED PATIENT WITH NO REPORTED CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722869 ↗
• MalfunctionAug 29, 2018Device Misassembled During Manufacturing /Shipping; Device Contamination with Chemical or Other Material; Packaging Problem; Device Misassembled During Manufacturing /Shipping; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT PRIOR TO A BIOPSY, ALLEGEDLY A ROUND TRANSPARENT PLASTIC PIECE WAS FOUND. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7831174 ↗
• MalfunctionJun 5, 2017Failure to Prime; Difficult to Remove; Failure to Obtain Sample; Failure to Prime; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE DEVICE ALLEGEDLY DID NOT FULLY CUT THE TISSUE. IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER ALLEGEDLY HAD DIFFICULTIES REMOVING THE NEEDLE FROM THE TISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6612730 ↗