N/A (REF B11LT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885825014278), received between Nov 9, 2016 and Oct 23, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 19, 2026Open, Classified

   Reusable access port system may crack or seperate during use.

   Z-3184-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE TROCAR CAP AND ENTIRE TOP PIECE OF TROCAR FELL APART AS SURGEON WAS PULLING GALLBLADDER OUT OF THE ABDOMEN. AS REPORTED, THE PIECES DID NOT FALL INTO THE PATIENT. THE OUTSIDE PORTION OF THE TROCAR FELL APART OUTSIDE OF THE PATIENT. ALL PIECES WERE RETRIEVED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 3-4 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368110 ↗
• InjuryMay 13, 2021Fracture; Fracture

  IT WAS REPORTED THE TROCAR BROKE OFF DURING SURGERY. THERE WAS NO PATIENT INJURY. AN X-RAY WAS TAKEN TO LOCATE ANY PIECES, BUT DID NOT SHOW UP ON THE FILM FOR THE RADIOLOGIST TO READ. NO ADDITIONAL INCISIONS WERE MADE OR MADE LARGER WHILE SEARCHING FOR IT. EXTENDED PROCEDURE TIME WAS 15 MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820630 ↗
• MalfunctionNov 9, 2016Break; Detachment Of Device Component

  IT WAS REPORTED WHEN THE SURGEON WENT TO SEW THE FASCIA, A PIECE OF THE TROCAR WAS DISCOVERED. THE PIECE WAS RETRIEVED AND MATCHED UP TO THE TROCAR TIP TO ENSURE ALL PIECES WERE RECOVERED BEFORE STITCHING UP THE PATIENT. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, AND EXTENDED PROCEDURE TIME REPORTED WAS MINIMAL. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6089385 ↗