Operon OT 8602165Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327170122), received between Nov 30, 2022 and Jul 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE D860 TABLE MOVED ON ITS OWN IN A TILT POSITION WITH THE HAND PENDANT DETACHED AND THE POWER CORD UNPLUGGED. THE PATIENT'S HEAD WAS SECURED WITH A HEAD-HOLDING APPARATUS. AS THE TABLE TILTED AND SLOWLY LOWERED, THE PATIENT'S HEAD WAS STILL SECURED, RESULTING IN THE PATIENT'S NECK BEING STRAINED. THE PATIENT IS DOING OKAY BUT WOKE UP WITH A SORE NECK. NO MEDICAL INTERVENTION WAS REQUIRED FOR THE REPORTED SORE NECK.

  Patient problems: Neck Pain

  MAUDE report 22654290 ↗
• MalfunctionSep 8, 2023Unintended Movement; Device Fell; Unintended Movement; Device Fell

  IT WAS REPORTED THAT IN THE MIDDLE OF THE CASE WHILE THE TABLE WAS IN TREND, WHEN THEY WENT TO LEVEL THE TABLE IT DROPPED TO LOWEST SETTING. IT WAS CLOSE TO A FOOT DROP. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17715955 ↗
• MalfunctionNov 30, 2022Mechanical Problem; Defective Component; Key or Button Unresponsive/not Working; Defective Component

  IT WAS REPORTED THAT AFTER PROCEDURE STARTED, WHEN PUTTING PATIENT IN REVERSE TRENDELENBURG, THE BED MALFUNCTIONED, AND THE CONTROL COMMAND BUTTON FAILED TO WORK PROPERLY. PATIENT WAS TRANSFERRED TO ANOTHER BED TO FINISH PROCEDURE. NO HARM TO PATIENT. BED REMOVED FROM SERVICE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES DUE TO THE DELAY OR ANY REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15889876 ↗