NA 397.211Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10887587041193), received between Dec 30, 2020 and Jul 29, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JULY 5, 2024, DURING ROUTINE MAINTENANCE IT WAS FOUND THAT THE ITEM DIDN¿T PROPERLY HOLD THE CANNULA. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE UNIVERSAL TROCAR HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT IS LINKED TO THE BELOW COMPLAINTS (B)(4) IS CREATED TO CAPTURE THE ALLEGATION AGAINST PRODUCT CODE 05.001.401.98. (B)(4) IS CREATED TO CAPTURE THE ALLEGATION AGAINST PRODUCT CODE 05.000.020. (B)(4) IS CREATED TO CAPTURE THE ALLEGATION AGAINST PRODUCT CODE 306.501. (B)(4) IS CREATED TO CAPTURE THE ALLEGATION AGAINST PRODUCT CODE 306.502.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19851594 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICES ARE BROKEN/FAULTY FROM OVERUSE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIVERSAL TROCAR HANDLE. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4). THIS (B)(4) IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721121 ↗
• MalfunctionJul 11, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICES ARE BROKEN/FAULTY FROM OVERUSE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIVERSAL TROCAR HANDLE. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4). THIS (B)(4) IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19721120 ↗
• MalfunctionJan 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE TROCAR WAS NOT PROPERLY LOCKING IN PLACE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) UNIVERSAL TROCAR HANDLE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13255946 ↗
• MalfunctionJan 13, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE TROCAR WAS NOT PROPERLY LOCKING IN PLACE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) UNIVERSAL TROCAR HANDLE. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13255921 ↗
• MalfunctionDec 30, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE TROCAR DID NOT HOLD THE CANNULA PROPERLY. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) UNIVERSAL TROCAR HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095350 ↗