LCP 03.113.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982072771), received between Aug 30, 2022 and Aug 30, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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 18, 2026.

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.

• MalfunctionAug 30, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022 THAT A TROCAR MAY HAVE BEEN WORN ON IT'S CONNECTION TO THE SLEEVE. THE SURGEON WAS NOTIFIED AND DECIDED TO USE THE TROCAR AND THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO ISSUES. THERE WAS NO PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) TROCAR H&LE F/3.5 LCP PERC INST SYS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15320135 ↗