Step S101010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521090764), received between Mar 25, 2019 and Mar 25, 2019 — classified as 1 malfunction.

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. Mar 1, 2023Open, Classified

   Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

   Z-1387-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2019Break; Detachment of Device or Device Component; Packaging Problem; Break; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING TOTAL LAPAROSCOPIC HYSTERECTOMY, UPON TROCAR INSERTION, THE INFERIOR PORTION OF THE TROCAR BROKE OFF AND FELL INTO THE ABDOMEN AND WAS RETRIEVED USING CRYO OR KELLY CLAMPS AND ADDISONS. IT WAS MENTIONED THAT THERE WAS TISSUE DAMAGE (BRUISING) FROM RETRIEVING THE PORTIONS THAT BROKE OFF FROM THE TROCAR. IT WAS NOTED THAT THEY WERE ABLE TO REMOVE ALL THE FRAGMENTS FROM THE PATIENT AS FAR AS THEY KNEW. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM WHICH WAS SPENT RETRIEVING THE LOST PIECE OF THE TROCAR, OPENING NEW SUPPLIES, AND CLEANING UP DEBRIS FROM THE TROCAR UPON CLOSING. IT WAS ALSO NOTED THAT THE INCISION WAS EXTENDED DUE TO THE PRODUCT PROBLEM BUT NOT MORE THAN 1 INCH. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient; Tissue Damage

  MAUDE report 8448399 ↗