N/A (REF 2B5LT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00885825017248), received between Aug 3, 2017 and Aug 21, 2026 — classified as 2 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (9 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-3182-2026 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380479 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50242281 ↗
• MalfunctionAug 13, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50237766 ↗
• MalfunctionJul 27, 2026No Apparent Adverse Event

  It was reported that the trocar broke on the sterile field. Multiple attempts were made to obtain additional information. No information was provided regarding patient injury, medical intervention, or extended procedure time reported. These are commonly used devices that are readily available.

  Patient problems: Insufficient Information

  MAUDE report 50015592 ↗
• MalfunctionJul 27, 2026No Apparent Adverse Event

  Patient problems: Insufficient Information

  MAUDE report 50014690 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50014689 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50014187 ↗
• MalfunctionJul 27, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50014185 ↗
• MalfunctionJul 27, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50014183 ↗
• MalfunctionMay 28, 2026Break

  IT WAS REPORTED THE TROCAR OBTURATOR TIP BREAKING OFF INTO THE PATIENT ABDOMINAL WALL. THE OBTURATOR ALSO DISASSEMBLED FROM THE TOP BLACK SECTION OF THE PART. IT WAS FURTHER REPORTED THE PIECE WAS REMOVED FROM THE PATIENT WITH NO FURTHER MEDICAL INTERVENTION. THERE WAS NO PATIENT INJURY REPORTED AND THE COMPLAINANT IS NOT AWARE OF ANY FURTHER MEDICAL INTERVENTION OR THE LENGTH OF THE EXTENDED PROCEDURE TIME. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25325225 ↗
• MalfunctionMay 20, 2026Break

  IT WAS REPORTED THEY HAVE A BROKEN TROCAR. OPENED IN BASIN AND IT SHATTERED. THEY OPENED ANOTHER TROCAR. 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 25235275 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THE TOP OF THE TROCAR SNAPPED OFF THE SHAFT WHEN PUTTING INTO PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 4 MINUTES FOR NURSE TO GET ANOTHER TROCAR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781892 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THE TOP OF THE TROCAR SNAPPED OFF THE SHAFT WHEN PUTTING INTO PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS 4 MINUTES FOR NURSE TO GET ANOTHER TROCAR. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24777740 ↗
• InjuryMar 6, 2026Fracture

  IT WAS REPORTED THAT THE TROCAR BROKE AT THE TIP WITH PLASTIC SHARDS DISLODGING. AS REPORTED, PIECES FELL INTO THE PATIENT AND WERE RETRIEVED. A CT SCAN WAS PERFORMED TO LOCATE THE PIECES AND A LARGER INCISION WAS NOT MADE TO RETRIEVE THE PIECES. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND EXTENDED PROCEDURE TIME REPORTED WAS THAT THE PATIENT WAS DELAYED BEING DISCHARGED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24538698 ↗
• InjuryMar 6, 2026Fracture

  IT WAS REPORTED THAT THE TROCAR BROKE AT THE TIP WITH PLASTIC SHARDS DISLODGING. AS REPORTED, PIECES FELL INTO THE PATIENT AND WERE RETRIEVED. A CT SCAN WAS PERFORMED TO LOCATE THE PIECES AND A LARGER INCISION WAS NOT MADE TO RETRIEVE THE PIECES. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THERE WAS NO OTHER PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AND EXTENDED PROCEDURE TIME REPORTED WAS THAT THE PATIENT WAS DELAYED BEING DISCHARGED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533997 ↗
• MalfunctionJul 17, 2019Break

  PATIENT WAS TAKEN TO THE OPERATING ROOM. GENERAL ANESTHESIA WAS INDUCED; PATIENT WAS PREPPED AND DRAPED IN A STANDARD STERILE FASHION. SURGEON THEN PROCEEDED TO DO A LAPAROSCOPIC APPENDECTOMY. TOWARDS THE END OF THE SURGERY, SURGEON ATTEMPTED TO REMOVE THE TROCAR FROM THE SLEEVE. THE OUTER END OF THE TROCAR JUST BROKE AND CRUMBLED INTO PIECES. NO HARM DONE TO THE PATIENT. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, REPROCESSED, N/A (PER SITE REPORTER). DEVICE IS WITH SURGERY INVENTORY COORDINATOR IN MATERIALS MANAGEMENT DEPARTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797961 ↗
• MalfunctionAug 3, 2017Break; Break

  IT WAS REPORTED THE TROCAR BROKE IN THE ABDOMEN OF THE PATIENT. ALL PIECES WERE REMOVED FROM THE PATIENT IN TWO MINUTES THROUGH THE OTHER TROCAR WITH A LAPAROSCOPIC GRASPER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6766011 ↗