MONOPTY 121816Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741084645), received between Feb 16, 2017 and Jul 12, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (7 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.

• MalfunctionJul 12, 2021Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12148957 ↗
• MalfunctionJun 9, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BIOPSY, THE DEVICE ALLEGEDLY SELF-ACTIVATED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11964289 ↗
• MalfunctionJun 2, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO THE BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY SELF ACTIVATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11918561 ↗
• MalfunctionApr 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT PRIOR TO BIOPSY THROUGH FIBROADENOMA TISSUE, THE DEVICE ALLEGEDLY HAD A BALL OF THREAD LIKE FOREIGN MATERIAL IN THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11723407 ↗
• MalfunctionFeb 2, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT PRIOR TO A BIOPSY, THE DEVICE ALLEGEDLY SELF-ACTIVATED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11264431 ↗
• MalfunctionJan 5, 2021Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BIOPSY, THE DEVICE ALLEGEDLY SELF-ACTIVATED AFTER ROTATING THE GRIP TWICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11115533 ↗
• InjuryAug 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LUNG BIOPSY, THE PATIENT ALLEGEDLY DEVELOPED A PNEUMOTHORAX. THE PATIENT STATUS IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 6818456 ↗
• MalfunctionMar 22, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING A KIDNEY BIOPSY, THE PHYSICIAN NOTICED THAT THE NEEDLE ALLEGEDLY APPEARED TO BE LONGER THAN WHAT WAS INDICATED ON THE PACKAGING LABEL AFTER TAKING ONE TISSUE SAMPLE. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND A COAXIAL WAS NOT USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6426625 ↗
• MalfunctionFeb 16, 2017Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A PROSTATE BIOPSY, THE BIOPSY INSTRUMENT FIRED AS THE HEALTH CARE PROVIDER WAS WITHDRAWING THE STYLET AND LOCKING THE BIOPSY INSTRUMENT INTO THE PRIMED POSITION . THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6337859 ↗
• MalfunctionFeb 16, 2017Self-Activation or Keying; Appropriate Device Problem Term/Code Not Available; Self-Activation or Keying

  IT WAS REPORTED THAT DURING PREPARATION FOR A PROSTATE BIOPSY ON THE FIRST SAMPLE ATTEMPT THE BIOPSY INSTRUMENT WAS FIRED ON ITS OWN AS THE HEALTH CARE PROVIDER WAS LOCKING THE DEVICE INTO THE PRIMED POSITION AT THE SECOND ROTATION. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient; No Patient Involvement

  MAUDE report 6337451 ↗