MONOPTY 121620Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741084621), received between Jun 28, 2018 and Oct 28, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (3 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.

• MalfunctionOct 28, 2025Break; Self-Activation or Keying; Device Dislodged or Dislocated; Break; Self-Activation or Keying; Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE MONOPTY DEVICE, UPON OPENING THE NEEDLE BOX, THE INSTRUMENT BODY WAS BROKEN. ANOTHER CANNULA NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23399703 ↗
• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN ECHO-GUIDED LIVER BIOPSY PROCEDURE, THE INNER CYLINDER HAD ALLEGEDLY TORE THE PATIENT'S GALLBLADDER WALL. IT WAS FURTHER REPORTED THAT THE PATIENT HAD ALLEGEDLY DEVELOPED CHOLECYSTITIS AFTER THE PROCEDURE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Rupture

  MAUDE report 21444596 ↗
• MalfunctionOct 16, 2019Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121620 BIOPSY INSTRUMENT ALLEGEDLY SELF-ACTIVATED. THERE WAS NO REPORTED PATIENT CONTACT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9200111 ↗
• MalfunctionJun 28, 2018Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY, THE DEVICE ALLEGEDLY WAS DIFFICULT TO PRIME. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7648499 ↗