NA 311.425Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034768700), received between Dec 4, 2019 and Jan 10, 2020 — classified as 2 malfunctions.

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

• MalfunctionJan 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE HANDLE WITH QUICK COUPLING WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE HANDLE WITH QUICK COUPLING. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575394 ↗
• MalfunctionDec 4, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A HANDLE WITH QUICK COUPLING WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9410888 ↗