MONOPTY 121610Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741084607), received between Mar 23, 2017 and Dec 21, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2023Self-Activation or Keying; Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information; Self-Activation or Keying; Device Misassembled During Manufacturing /Shipping; Insufficient Device Problem Information

  IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED BREAST BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY ALREADY ARMED AT THE OPENING AND DOES NOT WORK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18370663 ↗
• MalfunctionOct 21, 2023Difficult to Remove; Self-Activation or Keying; Difficult to Remove; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY GOT STUCK INSIDE THE PATIENT AND THEN FIRED ON ITS OWN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17982030 ↗
• MalfunctionApr 28, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, A BLACK MATERIAL IN THREE MILLIMETER SIZE WAS ALLEGEDLY FOUND IN THE PACKAGE BEFORE OPENING IT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16830912 ↗
• MalfunctionFeb 2, 2023Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281991 ↗
• MalfunctionApr 28, 2022Device Dislodged or Dislocated; Packaging Problem; Device Dislodged or Dislocated; Packaging Problem

  IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE, A GAP WAS ALLEGEDLY FOUND BETWEEN THE TWO PLATES OF THE GRIP. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239958 ↗
• MalfunctionJul 14, 2020Unsealed Device Packaging; Unsealed Device Packaging

  THIS REPORT SUMMARIZES FIVE MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121610 BIOPSY INSTRUMENT EXPERIENCED UNSEALED DEVICE PACKAGING. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTIONS DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10269151 ↗
• MalfunctionJan 9, 2020Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL 121610 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED FAILURE TO PRIME. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID NOT INVOLVE A PATIENT AS THERE WAS NO PATIENT CONTACT. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9570261 ↗
• MalfunctionJul 11, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121610 BIOPSY INSTRUMENT ALLEGEDLY HAD A BLACK FOREIGN MATERIAL. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE.

  Patient problems: No Patient Involvement

  MAUDE report 8783212 ↗
• MalfunctionOct 18, 2018Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, AFTER THE FIRST SAMPLE PASS, THE DEVICE ALLEGEDLY FAILED TO OBTAIN A TISSUE SAMPLE. IT WAS FURTHER REPORTED THAT THE TISSUE WAS ALLEGEDLY CAUGHT BETWEEN THE STYLET AND CANNULA, MAKING IT DIFFICULT TO REMOVE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7980930 ↗
• MalfunctionApr 6, 2018Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED AXILLARY GANGLION BIOPSY, THE TRIGGER OF THE DEVICE ALLEGEDLY WAS DIFFICULT TO PRESS. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH SAME DEVICE AND NO COAXIAL WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7405051 ↗
• MalfunctionAug 4, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A BREAST BIOPSY, THE HEALTH CARE PROVIDER ALLEGEDLY HAD DIFFICULTY REMOVING THE BIOPSY NEEDLE FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6767324 ↗
• MalfunctionMar 23, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PREPARATION FOR A BIOPSY, THE CANNULA NEEDLE ALLEGEDLY RELEASED WHILE PRIMING THE STYLET NEEDLE. THIS ALLEGEDLY HAPPENED INTERMITTENTLY WHILE PRIMING THE DEVICE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS PERFORMED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT

  Patient problems: No Patient Involvement

  MAUDE report 6430346 ↗