NA 242312Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705026265), received between Nov 3, 2021 and Mar 25, 2024 — 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. How this data works · Data updated Oct 13, 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 25, 2024Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED BY THE SALES REP IN HUNGARY THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE HD COUPLER DEVICE C MOUNT WAS FOGGY. ANOTHER COUPLER USED TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM TO THE PATIENT. THERE WAS A TWO MINUTE DELAY WHILE SWITCHING TO ANOTHER DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18970201 ↗
• MalfunctionNov 3, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT PREOPERATIVELY TO A SHOULDER ARTHROSCOPY SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT PART OF THE HD COUPLER, C-MOUNT 17MM DEVICE BROKE OFF. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12745697 ↗