MONOPTY 122016Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741084676), received between Jul 11, 2019 and Nov 9, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Self-Activation or Keying” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2020Adverse 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 HEMORRHAGE, AND 2 OCCURRENCES OF BLEEDING, ONE REQUIRING INTERVENTION, DURING LIVER BIOPSY PROCEDURE(S). IT WAS FURTHER REPORTED THERE WERE 3 OCCURRENCES OF HEMATURIA, 1 OCCURRENCE OF PSEUDOANEURYSM, AND 3 OCCURRENCES OF BLEEDING, TWO REQUIRING INTERVENTION, DURING KIDNEY BIOPSY PROCEDURE(S). THE CURRENT STATUS OF THE PATIENT(S) WAS NOT PROVIDED.

  Patient problems: Hematuria; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 10808534 ↗
• MalfunctionJul 11, 2019Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 122016 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED SELF-ACTIVATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783142 ↗