Radial setting clamp 100323C0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046768001787), received between Jul 1, 2024 and Jul 1, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Slipped” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2024Device Slipped; Device Slipped

  GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR ACCESSORIES - 100323C0 - RADIAL SETTING CLAMP. AS IT WAS STATED, THE RADIAL SETTING CLAMP SLIPPED LEADING TO QUICK DROP OF A BARIATRIC STIRRUP THAT WAS PLACED IN THE CLAMP. THE INCIDENT OCCURRED WHEN THE PATIENT¿S LEG WAS IN THE BOOT. ACCORDING TO THE CUSTOMER, THE TEETH WERE ALIGNED CORRECTLY, AND THE CLAMP WAS APPROPRIATELY TIGHTENED TO THE STIRRUP POLE, HOWEVER, THE DEVICE STILL DROPPED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE FAST UNINTENDED MOVEMENT DUE TO RADIAL SETTING CLAMP SLIPPING, WAS TO REOCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19642003 ↗