N/A (REF D12LT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885825015596), received between Feb 6, 2026 and Sep 9, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Break

  It was reported the Trocar broke and came apart where it is not supposed to. There was no patient injury or medical intervention and the extended procedure time reported was minimal. These are commonly used devices that are readily available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690364 ↗
• MalfunctionAug 26, 2026Break

  It was reported that the trocar broke while using on patient. The complainant is not aware of any patient injury, medical intervention, or extended procedure time. These are commonly used devices that are readily available.

  Patient problems: Insufficient Information

  MAUDE report 50444280 ↗
• MalfunctionJun 12, 2026Break

  IT WAS REPORTED THE TOP PORTION OF THE TROCAR DEVICE (VALVE AND VALVE RETAINER) BROKE OFF. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 5 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492039 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THE TOP OF THE TROCAR UNSCREWED AND FELL APART WHILE BEING HANDLED BY THE SURGEON. REPLACED WITH STRYKER DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795574 ↗
• MalfunctionFeb 6, 2026Melted

  IT WAS REPORTED A PIECE OF THE RUBBER VALVE BROKE OFF THE TROCAR WHEN AN OPERATING INSTRUMENT WAS INSERTED THROUGH IT. THE PIECE ENDED UP IN THE PATIENT'S ABDOMINAL CAVITY. AS REPORTED, THE PIECES WERE SEEN AND THEN RETRIEVED BY THE SURGEON. THE COMPLAINANT IS NOT AWARE OF ANY PATIENT INJURY AND THERE WAS NO MEDICAL INTERVENTION. EXTENDED PROCEDURE TIME REPORTED WAS "BRIEFLY (MINUTES)." THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24283908 ↗