n.a. 30104A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551118023), received between Nov 19, 2025 and Nov 19, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED: RECEIVED PHONE CALL FROM (B)(6) SISTERS (B)(6), TOLD THAT THE TROCAR WAS FOUND TO BE FAULTY AS THERE IS LEAKING OF GAS. CLOSER LOOK AT THE TROCAR REVEALED TO HAVE A MISSING SCREW. SCREW IS SUSPECTED TO CAME LOOSE AND WORRIED THAT IT MIGHT DROP INTO PATIENT. AN X-RAY SCAN WAS PERFORMED TO CONFIRM THAT NO METAL RESIDUE REMAINED IN THE PATIENT'S BODY. THE SCAN RETURNED AS NEGATIVE. NO RESIDUES IN PATIENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23595748 ↗
• InjuryNov 19, 2025Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED: RECEIVED PHONE CALL FROM (B)(6) SISTERS (B)(6), TOLD THAT THE TROCAR WAS FOUND TO BE FAULTY AS THERE IS LEAKING OF GAS. CLOSER LOOK AT THE TROCAR REVEALED TO HAVE A MISSING SCREW. SCREW IS SUSPECTED TO CAME LOOSE AND WORRIED THAT IT MIGHT DROP INTO PATIENT. AN X-RAY SCAN WAS PERFORMED TO CONFIRM THAT NO METAL RESIDUE REMAINED IN THE PATIENT'S BODY. THE SCAN RETURNED AS NEGATIVE. NO RESIDUES IN PATIENT.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23595740 ↗