ADVANCED CONTROL I-BASE, DC 5803Recalls & reported problems
Mizuho Orthopedic Systems, Inc. · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Mizuho Advanced Control i-Base is a powered surgical table used for orthopedic procedures. The 47 reports mostly describe the table shifting, tilting or collapsing unexpectedly — sometimes with a patient on it — leading to falls, with a few reports noting the tabletop falling off its base or locks not holding. There are 14 injuries and no deaths. No recalls name this device. Reports have dropped sharply, from 8 in the prior 12 months to 1 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 00842430106026), received between Jan 28, 2019 and Sep 30, 2026 — classified as 14 injuries, 33 malfunctions.
The most frequently reported specific device problem is “Unintended Movement” (17 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.
Reports received per month
Most reported problems
Device problems
- Unintended Movement17
- Insufficient Device Problem Information15
- Use of Device Problem14
- Device Fell4
- Improper or Incorrect Procedure or Method4
- Device Slipped3
- Unintended System Motion3
- Detachment of Device or Device Component2
Patient problems
- Fall22
- No Clinical Signs, Symptoms or Conditions16
- Insufficient Information9
- No Known Impact Or Consequence To Patient9
- No Information2
- Abrasion1
- Cardiac Arrest1
- Erythema1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Fall
MAUDE report 50941505 ↗MalfunctionJul 15, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THE DURING A PROCEDURE, PATIENT ON THE BED ROTATED ABRUPTLY ON ITS OWN. NO INJURY REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22511573 ↗MalfunctionMay 27, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT WHEN THE TILT FUNCTION ON THE TABLE WAS USED, THE LOCKS DID NOT HOLD LEADING THE TABLE TO SWING IN THE OPPOSITE DIRECTION AND CAUSING THE PATIENT TO FALL.
Patient problems: Fall
MAUDE report 22089961 ↗MalfunctionApr 26, 2025Unintended Movement; Unintended Movement
TABLE STARTED TILTING ON ITS OWN WITH A PATIENT ON THE TABLE. ROTATIONAL SAFETY LOCK WAS ENGAGED AS WELL AS A 180 DEGREE ROTATIONAL LOCK HANDLE. NO FUNCTIONS ON HAND PENDANT WERE PRESSED AS PER STAFF WHEN INCIDENT OCCURRED. NO PATIENT INJURY/HARM REPORTED BY STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21915668 ↗MalfunctionMar 25, 2025Use of Device Problem; Device Fell; Use of Device Problem; Device Fell
IT WAS REPORTED THAT THE END USER PULLED THE T-PIN OUT OF THE TABLE CAUSING THE TABLE TOP TO FALL OFF THE TABLE BASE WITH PATIENT ON THE TABLE. NO PATIENT INJURY/HARM REPORTED.
Patient problems: Fall; No Clinical Signs, Symptoms or Conditions
MAUDE report 21689305 ↗MalfunctionMar 25, 2025Unintended System Motion; Insufficient Device Problem Information; Unintended System Motion; Insufficient Device Problem Information
WHILE REPOSITIONING THE PATIENT, THE TABLE SHOWED LOCKED, BUT IT ROTATED CAUSING THE PATIENT TO FALL.
Patient problems: Abrasion; Insufficient Information
MAUDE report 21688730 ↗InjuryMar 25, 2025Use of Device Problem; Device Fell; Use of Device Problem; Device Fell
IT WAS REPORTED THAT DURING A SURGERY WRONG H FRAME PIN WAS PULLED BY STAFF CAUSING THE PATIENT TO FALL.
Patient problems: Fall; Insufficient Information
MAUDE report 21688158 ↗MalfunctionFeb 12, 2025Use of Device Problem; Detachment of Device or Device Component; Insufficient Device Problem Information; Use of Device Problem; Detachment of Device or Device Component; Insufficient Device Problem Information
DURING PATIENT TRANSFER, PATIENT FELL OFF THE TABLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21370423 ↗MalfunctionDec 20, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT A PATIENT ALMOST FELL OFF THE TABLE BUT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20992983 ↗InjuryAug 29, 2024Use of Device Problem; Use of Device Problem
PATIENT FELL FROM MTS TABLE. THE TABLE WAS USED FOR A SURGICAL PROCEDURE WITHOUT A T-PIN. WHEN THE PATIENT WAS BEING TRANSFERRED FROM THE OPERATING TO THE GURNEY, THE HEAD SIDE OF THE TABLE DROPPED CAUSING THE PATIENT TO FALL.
Patient problems: Fall
MAUDE report 20103620 ↗MalfunctionAug 6, 2024Unintended Movement; Unintended Movement
PATIENT WAS ON OR BED, AND BED UNEXPECTEDLY MOVED, LEFT SIDE TILTED DOWN. STAFF WAS ABLE TO PREVENT THE PATIENT FROM FALLING, NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919952 ↗MalfunctionJul 16, 2024Use of Device Problem; Unintended Movement; Use of Device Problem; Unintended Movement
WHEN THE TABLE WAS TOLD TO TILT, IT TILTED IN THE OPPOSITE DIRECTION, FULL TILT,
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19756950 ↗InjurySep 20, 2023Use of Device Problem; Use of Device Problem
PATIENT TRANSFERRED TO OPERATION TABLE. THE HEAD END ROTATION KNOB WAS LOCKED, AND THE FOOT END COLUMN WAS NOT LOCKED. STAFF NOTICED SOME INSTABILITY IN THE TABLE AND SWUNG OUT FROM THE PATIENT. THE PATIENT FELL TO THE FLOOR. THE PATIENT WAS EXAMINED; RECEIVED CT SCANS AND TRAUMA WORK-UP WITH NO IDENTIFIED PHYSICAL CONCERNS FROM THE INCIDENT.
Patient problems: Fall
MAUDE report 17786399 ↗InjuryJul 11, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
InjuryMay 22, 2023Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
A PATIENT INCIDENT WAS REPORTED IN THE MIDDLE OF THE CASE. PATIENT WAS SLIDING OFF THE IMAGING TOP WHEN THE STAFF NOTICED IT AND BEFORE THE PATIENT FELL THEY CAUGHT HIM BY THE FEET AND HEAD AND LOWERED THE PATIENT TO THE FLOOR. NO PATIENT INJURY REPORTED AT THIS TIME.
Patient problems: Fall
MAUDE report 16976652 ↗MalfunctionApr 10, 2023Unintended Movement; Unintended Movement
IT WAS REPORTED THAT DURING A CASE A PATIENT ALMOST DROPPED OFF THE TABLE. THE HOSPITAL STAFF WENT TO LEVEL THE TABLE BUT RATHER THAN LEVEL IT TILTED FURTHER. THE STAFF CAUGHT THE PATIENT. NO PATIENT INJURY OCCURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16709459 ↗MalfunctionDec 30, 2022Unintended Movement; Unintended Movement
TABLE TILTED UNEXPECTEDLY DURING SURGERY. PERSONNEL CAUGHT IT AND LOCKED IT BACK IN PLACE. NO INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16079901 ↗MalfunctionDec 2, 2022Unintended Movement; Unintended Movement
IT WAS REPORTED THAT MIZUHO OSI TABLE WAS BEING USED WITH A MAPPING SYSTEM AND STAFF UNLOCKED THE TABLE TO ROLL IT BUT PATIENT ROLLED OFF THE TABLE IN DOING SO. NO REPORTED PATIENT INJURY. HOSPITAL STAFF SLOWLY LOWERED THE PATIENT TO THE GROUND. THE PATIENT WAS LIFTED BACK TO ANOTHER BED FOR IMAGING AND SAFETY PRECAUTIONS. CASE WAS CANCELLED AND RESCHEDULED FOR NEXT DAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15901487 ↗MalfunctionAug 31, 2022Use of Device Problem; Use of Device Problem
DURING A CASE STAFF DID NOT LOCK THE ROTATION SAFETY LOCK AND TABLE TILTED AND PATIENT FELL OFF. REPORTED PATIENT WAS NOT HURT. WENT THROUGH X RAYS AND NO INJURIES WERE REPORTED.
Patient problems: Fall
MAUDE report 15332157 ↗MalfunctionAug 17, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
IT WAS REPORTED THAT THE TABLE TOP FELL WTH A PATIENT ON DURING SURGERY. THE REPORTER INDICATED THAT THE ISSUE OCCURED WITH THE PIN AT THE H-FRAME OF THE TABLE. PATIENT CODED 20 MINUTES LATER BUT THE REPORTER WAS NOT SURE IF THIS WAS DUE TO THE DROP OF BECAUSE OF THE SURGERY.
Patient problems: Cardiac Arrest
MAUDE report 15245982 ↗MalfunctionJul 12, 2022Device Dislodged or Dislocated; Misassembly by Users; Device Dislodged or Dislocated; Misassembly by Users
IT WAS REPORTED THAT THE HEAD END OF THE TABLE TOP FELL WITH A PATIENT ON DURING SURGERY.
Patient problems: Fall; Insufficient Information
MAUDE report 14986665 ↗MalfunctionJun 30, 2022Improper or Incorrect Procedure or Method; Insufficient Device Problem Information; Improper or Incorrect Procedure or Method; Insufficient Device Problem Information
IT WAS REPORTED THAT THE ROTATION LOCK OF THE SURGERY TABLE WAS NOT HOLDING WHICH CAUSED THE TABLE TO TILT WITH PATIENT ON IT.
Patient problems: Fall; No Clinical Signs, Symptoms or Conditions
MAUDE report 14876899 ↗InjuryJun 8, 2022Use of Device Problem; Use of Device Problem
IT WAS REPORTED THAT THE TABLE FELL.
Patient problems: Fall; Insufficient Information
MAUDE report 14640383 ↗MalfunctionMar 8, 2022Misassembly by Users; Misassembly by Users
TABLETOP FELL DURING PATIENT TRANSFER. T-PIN WAS NOT CONNECTING FRAME TO CROSSBAR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13694892 ↗MalfunctionMar 8, 2022Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
WHILE PREPARING TO TRANSFER PATIENT AFTER PROCEDURE, TABLETOP ROTATED 90 DEGREES AND PATIENT FELL TO FLOOR.
Patient problems: Fall
MAUDE report 13694473 ↗
Other Table, Surgical With Orthopedic Accessories, Ac-Powered devices
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- TS 7500 1854087Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED1 recall0 reports
- TRUMPF MEDICAL 1723633Baxter Medical Systems GmbH + Co. KG · TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED43 reports
- TABLE, HANA, 110 V 6875Mizuho Orthopedic Systems, Inc. · Table, Surgical With Orthopedic Accessories, Ac-Powered2 deaths36 reports
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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