N/A (REF CB12LT)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885825014438), received between Oct 12, 2017 and Apr 21, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THE INNER PLASTIC SEAL POPPED OUT OF THE TROCAR SLEEVE AND WAS IN PATIENT. 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 24947923 ↗
• MalfunctionFeb 19, 2026Material Fragmentation

  IT WAS REPORTED THAT THE TIP OF THE TROCAR BROKE OFF INSIDE OF THE PATIENT. AS REPORTED, THERE TROCAR SLEEVES WERE REPROCESSED BY STRYKER SUSTAINABILITY SOLUTIONS. IT IS UNKNOWN HOW MANY TIMES THIS DEVICE WAS REPROCESSED. IT WAS REPORTED THAT PIECES OF THE DEVICE FELL INTO THE PATIENT AND WERE ABLE TO BE RETRIEVED. A LARGER INCISION WAS NOT MADE TO RETRIEVE THE PIECES AND AN X-RAY WAS NOT USED TO LOCATE THE PIECES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND THE COMPLAINANT IS NOT AWARE OF ANY EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24390794 ↗
• MalfunctionJan 22, 2026

  TIP OF TROCAR BROKE OFF INSIDE OF PATIENT. THESE TROCAR SLEEVES ARE REPROCESSED BY STRYKER SUSTAINABILITY SOLUTIONS. IT IS UNKNOWN HOW MANY TIMES THIS DEVICE WAS REPROCESSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24144307 ↗
• InjuryJun 13, 2024Fracture; Use of Device Problem; Fracture; Use of Device Problem

  IT WAS REPORTED THAT THE TROCAR TIP WAS BROKEN AND PIECES STILL REMAIN IN PATIENT. THERE WAS NO MEDICAL INTERVENTION OR EXTENDED PROCEDURE TIME REPORTED. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19534163 ↗
• InjuryApr 28, 2023Break; Break

  IT WAS REPORTED THE DEVICE SLEEVE SPLINTERED OFF INTO THE PATIENT. THE VISIBLE PIECES WERE RETRIEVED DURING THE CASE BY PICKING THEM OUT. NO LARGER INCISION WAS MADE TO RETRIEVE THE PIECES. ULTRASOUND WAS USED TO CHECK FOR ANY REMAINING PLASTIC LEFT, BUT IT WAS REPORTED THAT THIS TESTING WAS NOT CONCLUSIVE. THE COMPLAINANT IS NOT AWARE OF THE DURATION OF EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834592 ↗
• InjuryApr 28, 2023Break; Break

  IT WAS REPORTED THE DEVICE SLEEVE SPLINTERED OFF INTO THE PATIENT. THE VISIBLE PIECES WERE RETRIEVED DURING THE CASE BY PICKING THEM OUT. NO LARGER INCISION WAS MADE TO RETRIEVE THE PIECES. ULTRASOUND WAS USED TO CHECK FOR ANY REMAINING PLASTIC LEFT, BUT IT WAS REPORTED THAT THIS TESTING WAS NOT CONCLUSIVE. THE COMPLAINANT IS NOT AWARE OF THE DURATION OF EXTENDED PROCEDURE TIME. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834573 ↗
• MalfunctionOct 12, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THE WASHER FELL OFF OF THE TROCAR DURING PROCEDURE. THE WASHER DID NOT FALL INTO THE PATIENT. THE PIECE WAS EASILY RETRIEVED. THE DEVICE WAS REPLACED WITH ANOTHER TROCAR TO COMPLETE THE 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 Consequences Or Impact To Patient

  MAUDE report 6946503 ↗