MONOPTY 121820Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741084652), received between Mar 19, 2018 and Aug 10, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Self-Activation or Keying” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2021Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging; Unsealed Device Packaging; Device Damaged Prior to Receipt by User; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY DAMAGED DUE TO HEAT AND STERILE BARRIER WAS ALLEGEDLY BREACHED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299909 ↗
• MalfunctionAug 6, 2021Failure to Prime; Self-Activation or Keying; Failure to Prime; Self-Activation or Keying

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286062 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A POST-MARKET CLINICAL FOLLOW-UP SURVEY ON CORE BIOPSY INSTRUMENTS, THERE WAS 1 OCCURRENCE OF BLEEDING DURING LIVER BIOPSY PROCEDURE. IT WAS FURTHER REPORTED THAT THE TREATMENT PROVIDED WAS ANGIOGRAM WITH EMBOLIZATION. THERE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11277315 ↗
• MalfunctionNov 10, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN OBJECT WAS IDENTIFIED WITHIN THE PACKAGING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10815557 ↗
• MalfunctionApr 9, 2020Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL 121820 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED DIFFICULT TO REMOVE AND FAILURE TO OBTAIN SAMPLE. THE REPORT WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE 71 YEAR OLD MALE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9944297 ↗
• MalfunctionApr 27, 2018Bent; Break; Material Twisted/Bent; Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING PREPARATION FOR THE BIOPSY PROCEDURE THE STYLET WAS ALLEGEDLY BENT AND CRACKED NEAR THE SAMPLE NOTCH OF THE DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 7470789 ↗
• MalfunctionMar 19, 2018Self-Activation or Keying; Failure to Fire; Device Misassembled During Manufacturing /Shipping; Self-Activation or Keying; Failure to Fire; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING A KIDNEY BIOPSY, THE DEVICE ALLEGEDLY FAILED TO FIRE ON THE FIRST SAMPLE PASS. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7349693 ↗