MONOPTY 121616Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741084614), received between Feb 23, 2018 and Dec 11, 2023 — classified as 3 injuries, 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Nonstandard Device; Self-Activation or Keying; Nonstandard Device; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY FIRED BEFORE TWO TURNS OF THE GRIP. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299990 ↗
• MalfunctionDec 9, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING AN ECHO-GUIDED MAMMARY GLAND BIOPSY PROCEDURE, ON LOCKING THE INNER NEEDLE FOR THE SECOND TIME, THE OUTER CYLINDER ALLEGEDLY FIRED BEFORE THE GRIP WAS TURNED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18298163 ↗
• MalfunctionNov 11, 2023Self-Activation or Keying; Self-Activation or Keying

  IT WAS REPORTED THAT DURING A RENAL BIOPSY PROCEDURE, THE NEEDLE SHOT OUT ON ITS OWN DURING PUNCTURE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS TAKEN OUTSIDE THE BODY AND ROTATED, THE NEEDLE FIRED ON ITS OWN IN THE SAME WAY AS BEFORE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117047 ↗
• 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 12299924 ↗
• MalfunctionAug 8, 2021Self-Activation or Keying; Self-Activation or Keying

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12292188 ↗
• MalfunctionJun 23, 2021Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12049596 ↗
• MalfunctionMay 17, 2021Difficult to Remove; Failure to Obtain Sample; Difficult to Remove; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED KIDNEY BIOPSY THROUGH NORMAL DENSITY TISSUE, THE NEEDLE OF THE DEVICE ALLEGEDLY STUCK ON TISSUE AND FAILED TO OBTAIN SAMPLES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11831020 ↗
• MalfunctionJul 13, 2020Self-Activation or Keying; Self-Activation or Keying

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 121616 BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED SELF-ACTIVATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10266797 ↗
• MalfunctionOct 3, 2018Self-Activation or Keying; Failure to Obtain Sample; Self-Activation or Keying; Failure to Obtain Sample

  IT WAS REPORTED THAT DURING A RENAL PROCEDURE THE BIOPSY INSTRUMENT ALLEGEDLY DID NOT OBTAIN ANY TISSUE SAMPLE. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7930640 ↗
• InjuryApr 6, 2018Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT PRIOR TO THE CT-SCAN-GUIDED LIVER BIOPSY INTO A NORMAL DENSITY TISSUE, THE DEVICE WAS INSPECTED PRIOR TO USE AND WAS DRY-FIRED OUTSIDE OF THE PATIENT. DURING THE BIOPSY, THE NEEDLE OF THE DEVICE ALLEGEDLY GOT STUCK IN THE LIVER AND WAS ALLEGEDLY DIFFICULT TO REMOVE FROM THE TISSUE, THEREFORE THE NEEDLE WAS MANUALLY REMOVED. NO TISSUE SAMPLES WERE ABLE TO BE OBTAINED AND NO COAXIAL WAS USED FOR THIS PROCEDURE. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED SEVERE PAIN UPON AWAKENING AND INTRA-VESICULAR BLEEDING WAS OBSERVED. THE PATIENT WAS FURTHER HOSPITALIZED AND GIVEN ANALGESIC TREATMENT. REPORTEDLY, THE PATIENT IS BEING MONITORED FOR POSSIBLE CHOLECYSTOSTOMY.

  Patient problems: Pain

  MAUDE report 7404217 ↗
• InjuryFeb 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST KIDNEY BIOPSY, THE PATIENT ALLEGEDLY HAD MACROSCOPIC HEMATURIA. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Hematuria

  MAUDE report 7294791 ↗
• InjuryFeb 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST KIDNEY BIOPSY, THE PATIENT ALLEGEDLY HAD MACROSCOPIC HEMATURIA.

  Patient problems: Hematuria

  MAUDE report 7293098 ↗