NA 242524Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705028221), received between Aug 12, 2022 and Mar 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 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.

• MalfunctionMar 22, 2023Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN AN IN-SERVICE HOSTED AT THE USER FACILITY, IT WAS OBSERVED THAT THE DUAL STOPCOCK SHEATH 5.9MM X 30 DEG X 167MM DEVICE, DUAL STOPCOCK SHEATH 1.9MM, 30DEG, 60MM DEVICE AND SINGLE STOPCOCK SHEATH 1.9MM, 30DEG, 60MM DEVICE WERE DENTED THAT THEY DID NOT ALLOW AN OBTURATOR TO GO THROUGH THEM. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592187 ↗
• MalfunctionAug 12, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPY PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SINGLE STOPCOCK SHEATH 1.9MM, 30DEG, 60MM (STORZ STYLE) DEVICE WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15215920 ↗