Advanced Control I-Base DC International 5803IRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00842430106002), received between Jul 24, 2019 and May 29, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2026Use of Device Problem

  ON MAY 11, 2026, A REPORT WAS RECEIVED FROM (B)(6) CENTER INDICATING THAT A PATIENT OVERTURNED DURING SPINE SURGERY. REVIEW OF A FOLLOW-UP CALL AND VIDEO INDICATED THAT BOTH THE ELECTRICAL AND MECHANICAL SAFETY LOCKING MECHANISMS OF THE TABLE WERE INADVERTENTLY RELEASED, LIKELY DUE TO LACK OF USER FAMILIARITY. THE TABLE SUBSEQUENTLY ROTATED APPROXIMATELY 180 DEGREES, RESULTING IN THE PATIENT TURNING OVER. PATIENT LANDED ON HIS FEET. NO PATIENT INJURY REPORTED. THE HOSPITAL'S INTERNAL INVESTIGATION CONCLUDED THE EVENT WAS DUE TO USER ERROR, WITH STAFF MANIPULATING THE REAR BLUE COMPONENT AND OPERATING THE REMOTE CONTROL IN AN ATTEMPT TO UNDERSTAND AND RELEASE THE MECHANISM. ON (B)(6) 2026, THE CUSTOMER CONFIRMED THAT STAFF TRAINING WAS CONDUCTED ON OPERATION OF THE TABLE LOCKING MECHANISMS AND INTERPRETATION OF INDICATOR LIGHTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337921 ↗
• MalfunctionApr 22, 2026Use of Device Problem; Misassembled During Installation

  DURING A SURGICAL PROCEDURE, AN INCIDENT WAS OBSERVED IN WHICH THE TREATMENT PLATE LOCKING MECHANISM APPEARED TO BE IN THE CLOSED POSITION BUT WAS NOT FULLY ENGAGED. AS A RESULT, DURING TABLE TILT, THE PLATE MOVED TO AN EXTREME TILT POSITION. A THOROUGH INSPECTION OF ALL MECHANICAL COMPONENTS WAS CONDUCTED, AND ALL WERE CONFIRMED TO BE FUNCTIONING AS INTENDED. ATTEMPTS TO REPLICATE THE ISSUE UNDER CONTROLLED SIMULATION CONDITIONS WERE UNSUCCESSFUL. FOLLOWING DISCUSSIONS WITH THE MEDICAL STAFF PRESENT, INCLUDING THE SURGEON AND ANESTHESIOLOGIST, IT WAS DETERMINED THAT THE LOCKING HANDLE HAD NOT BEEN FULLY SECURED. THE STAFF WAS SUBSEQUENTLY INSTRUCTED ON VERIFYING FULL LOCKING ENGAGEMENT PRIOR TO USE. AFTER COMPLETION OF ALL INSPECTIONS, THE TABLE WAS CONFIRMED TO BE OPERATING CORRECTLY. AT THE REQUEST OF THE BIOMEDICAL ENGINEERING DEPARTMENT, THE LOCKING HANDLE ALIGNMENT WAS ADJUSTED ON ALL TABLES OF THE SAME MODEL, AND ALL UNITS HAVE BEEN CLEARED AND ARE READY FOR OPERATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24955754 ↗
• InjuryNov 11, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REPORTED THAT A PATIENT FELL OFF THE TABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12801293 ↗
• InjuryMar 16, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT WAS ROTATED ON THE JACKSON TABLE INTO THE SUPINE POSITION WHEN THE STAFF WENT TO REMOVE THE H-FRAME AND T PINS THEY INCORRECTLY REMOVED THE WRONG T PIN CAUSING THE PATIENT TO FALL OFF THE TABLE. THIS WAS A USER ERROR NOT A ISSUE WITH THE TABLE, HOWEVER THEY HAVE REPORTED THE INCIDENT AS THEY REQUIRE A SERVICE ENGINEER TO CONFIRM THE TABLE IS IN WORKING ORDER, A PREVENTATIVE MAINTENANCE REQUEST HAS BEEN INSTIGATED FOR THE HOSPITAL.

  Patient problems: Fall; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11494332 ↗
• MalfunctionJul 24, 2019Fracture; Device Slipped; Fracture; Device Slipped

  IT WAS REPORTED; THE BASE IS REPORTED TO HAVE SUFFERED A CATASTROPHIC FAILURE. DURING THE PROCEDURE ON SUNDAY 10 MARCH THE SURGEON REQUESTED SCREENING WITH THE C-ARM. THE C-ARM WAS POSITIONED AND WHILE SCREENING TOOK PLACE, A LOUD "CLICKING" NOISE WAS AUDIBLE COMING FROM THE HEAD OF THE TABLE. AFTER THE ARM WAS REMOVED AND THE PROCEDURE CONTINUED, ANOTHER LOUD NOISE (AS IF A MECHANICAL PART BREAK) WAS HEARD AND THE TABLE TILTED TO THE RIGHT. THE SURGEONS MANAGED TO STOP THE TILTING ACTION. TO SECURE THE TOP, THE BED WAS ELEVATED AND TWO WOUND TROLLEYS PLACED BELOW THE SURFACE AND BOARD. IT WAS SLOWLY LOWERED TO THE TOUCHING POINT AND THE PROCEDURE COMMENCED. THE PATIENT WAS TRANSFERRED TO AN ALTERNATIVE PROCEDURE TABLE AND THE PROCEDURE CONTINUED. DUE TO THE E-RING FALLING OUT WHICH ALLOWED THE SHAFT TO MOVE OUT OF PLACE AND AS THE SHAFT MOVED FREELY DOWNWARD IT CAUSED AN ANGLED FORCE WHICH CAUSED THE CASING MOUNT ON THE TILT MOTOR ASSEMBLY ON THE MOTOR TO BREAK. TO DATE, MIZUHO OSI HAS NEVER SEEN THIS TYPE OF FAILURE DURING NORMAL USE. ALSO, IT WAS OBSERVED IN THE PREVENTATIVE MAINTENANCE REPORT, THAT THE CHECKLIST WAS NOT COMPLETED, INDICATING THAT THEY WERE NOT PERFORMED, OR THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8824184 ↗