Operon OT 8602065Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327170160), received between Apr 23, 2021 and Jun 24, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2026Unintended Collision

  IT WAS REPORTED THAT IN A SURGERY WHEN TRYING TO LOWER THE BED IN REVERSE TREND, THE D860 TABLE HEIGHT DROPPED OUT FROM UNDER THE PATIENT ABRUPTLY TO THE LOWEST HEIGHT. AFTER THAT HAPPENED, THEY WERE ABLE TO CONTINUE TO USE THE TABLE, ALL FUNCTIONS APPEARED TO WORK AND THEY WERE ABLE TO COMPLETE THE PROCEDURE. IT WAS LATER DETERMINED THAT THEY HAD A MISTRAL-AIR MACHINE UNDER THE LEG SECTION OF THE TABLE AND LOWERED THE TABLE AND ONLY THE HEAD SIDE LOWERED UNTIL THEY KICKED OUT THE MACHINE AND THE TABLE DROPPED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25612520 ↗
• MalfunctionJul 3, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE D860 TABLE RAISED AND LEVELED WITHOUT ANYONE TOUCHING THE TABLE WHILE THE PATIENT WAS ON THE TABLE AND WITH TROCARS INSIDE THE BODY. THE FOOT END OF THE TABLE (THE TABLE WAS IN REVERSE TRENDELENBURG) STARTED TO LEVEL AND AFTER IT LEVELED OUT THE ENTIRE TABLE ROSE SLIGHTLY. THE ANESTHESIOLOGIST DID NOT HAVE THE CONTROL PENDANT IN THEIR HAND AND AS THE FOOT END STARTED TO RISE, THE ANESTHESIOLOGIST TOOK THE CONTROL PIECE AND TRIED TO STOP IT BUT IT DID NOT WORK. THE PHYSICIAN TOOK ABOUT 5 TO 8 MINUTES TO VERIFY THAT NO DAMAGE HAD BEEN DONE AND THAT THE CASE COULD BE COMPLETED SAFELY. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667553 ↗
• InjuryJan 3, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE TABLE MOVED UNEXPECTEDLY. THEY WERE PUTTING THE TABLE IN REVERSE MODE AND WHEN THEY MOVED IT, THE TABLE JERKED. THE DOCTOR HAD BEEN HOLDING A CAMERA UNDER THE KIDNEY WHEN IT HAPPENED AND IT PIERCED THE KIDNEY WHICH REQUIRED MEDICAL INTERVENTION.

  Patient problems: Laceration(s)

  MAUDE report 18440129 ↗
• MalfunctionDec 21, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE D860 TABLE (S/N: (B)(6) IS MOVING INTO TREND POSITION AT RANDOM ON IT'S OWN. THERE WAS CURRENTLY A PATIENT ON THE TABLE, BUT THE SURGEON DECIDED TO CONTINUE THE CASE WITH THIS TABLE. PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT HAD AN OPEN INCISION. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18374804 ↗
• MalfunctionFeb 23, 2023Unintended System Motion; Unintended System Motion

  IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS UNINTENDED MOVEMENT OF THE TABLE. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16433394 ↗
• MalfunctionApr 15, 2022Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THE BACK SECTION OF THE D860 TABLE CAME OFF WHEN PUTTING IT INTO THE TREND POSITION. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117602 ↗
• MalfunctionDec 1, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE THERE WAS UNINTENDED MOVEMENT OF THE TABLE AFTER BEING LOWERED ON AN EXTERNAL PIECE OF EQUIPMENT. THERE WERE NO REPORTED INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909411 ↗
• InjuryApr 23, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED WHEN THE TABLE WAS MOVED INTO POSITION THE TABLE EXPERIENCED UNINTENDED MOVEMENT AFTER BEING CAUGHT ON AN EXTERNAL PIECE OF EQUIPMENT DURING A PROCEDURE. THE UNINTENDED MOVEMENT RESULTED IN PATIENT INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11713583 ↗