N/A (REF B5LT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00885825014193), received between Oct 31, 2022 and Sep 16, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Fracture” (11 reports).

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-3186-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50796740 ↗
• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50124023 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015252 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015247 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015177 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015175 ↗
• MalfunctionJul 27, 2026Fracture

  It was reported that the trocar arrived broken in packaging. 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 50015083 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50015082 ↗
• MalfunctionMay 8, 2026Fracture

  IT WAS REPORTED A TROCAR ARRIVED BROKEN IN PACKAGING. 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 25125273 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THE TROCAR WAS BROKEN UPON OPENING, FELL APART. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093154 ↗
• MalfunctionMay 1, 2026Fracture

  IT WAS REPORTED, "BROKEN TROCAR." IT WAS FURTHER REPORTED THE DEVICE WAS BROKEN WHEN THEY OPENED THE PACKAGING AND WAS NOT USED IN A PROCEDURE. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25056535 ↗
• MalfunctionApr 17, 2026Fracture

  IT WAS REPORTED THE TROCAR FELL APART INSIDE THE PATIENT. THEY WERE ABLE TO RETRIEVE THE PIECES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION, AND THE DURATION OF THE EXTENDED PROCEDURE TIME WAS NOT KNOWN BUT THEY HAD TO GET THE PIECES OUT OF THE PATIENT. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24914895 ↗
• InjuryDec 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE 5MM PLASTIC TROCAR TIP BROKE OFF. AN X-RAY WAS TAKEN WITH NO EVIDENCE OF PRESENCE IN THE ABDOMEN. THE PATIENT WENT FROM PACU TO CT. AS REPORTED, THE PATIENT HAD TO HAVE A CT SCAN POST-OP. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THERE WAS NO EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850663 ↗
• MalfunctionMar 10, 2025Fracture; Fracture

  IT WAS REPORTED THE TIP OF THE TROCAR BROKE OFF. AS REPORTED, THE FRACTURED PIECE BROKE OFF BEFORE USE ON THE PATIENT. THE TIP OF THE DEVICE WAS REPORTED TO NOT HAVE BROKEN OFF COMPLETELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21568463 ↗
• InjuryApr 22, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THE CLEAR TIP AT THE END OF THE COMPLAINT DEVICE BROKE OFF INTO THE PATIENT AND, ALTHOUGH THE TEAM DID THEIR DID DILIGENCE IN THE OR TO LOOK FOR IT, IT WAS NOT IDENTIFIED VIA ULTRASOUND UNTIL AFTER THE PATIENT LEFT THE OR. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT WAS BROUGHT BACK INTO THE OR A FEW DAYS LATER TO REMOVE THE PIECE DURING A SECOND SURGERY. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND THE COMPLAINANT IS NOT AWARE OF THE EXTENDED PROCEDURE DURATION. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160764 ↗
• InjuryOct 31, 2022Break; Break

  IT WAS REPORTED THAT THE "TIP OF OBTURATOR TROCAR BROKE OFF IN THE PATIENT DURING THE "OPTIVIEW" PORTION OF THE PROCEDURE." THE TIP GOT STUCK IN THE PATIENT'S FASCIA. THE DOCTOR USED AN X-RAY, AND THE CASE TURNED INTO AN OPEN PROCEDURE TO RETRIEVE THE BROKEN PIECES. IT WAS REPORTED THAT THEY COULD NOT FIND THE BROKEN PIECES. EXTENDED PROCEDURE TIME WAS REPORTED, BUT NO INFORMATION WAS PROVIDED REGARDING THE LENGTH OF THE EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15705157 ↗