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TABLE, ProAxis 6988Recalls & reported problems

Mizuho Orthopedic Systems, Inc. · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00842430107023), received between Jan 20, 2020 and Aug 29, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Handling Problem” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Handling Problem1
  • Electrical Shorting1
  • Misconnection1
  • Smoking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Pressure Sore/Ulcer1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 29, 2023Misconnection; Smoking; Electrical Shorting; Device Handling Problem; Misconnection; Smoking; Electrical Shorting; Device Handling Problem

    AN ELECTRICAL WIRE CORD BURN WITH CHARRING AND SMOKE WAS REPORTED ON PROAXIS TABLE. THE CORD WAS CHANGED WHEN THE PATIENT WAS ALREADY ON THE TABLE. ONCE THEY TURNED THE POWER ON AND STARTED THE CASE AGAIN ANESTHESIA SMELLED AN ELECTRICAL BURNING SMELL AND NOTICED CHARRING AND SMOKE AT THE CORD GOING INTO THE TABLE. THERE WAS ALSO CHARRING AROUND WHERE THE CORD ENTERS THE TABLE AS WELL AS CHARRING OF SOME IV TUBBING AS OBSERVED BY OR STAFF. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17643624 ↗
  • InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE TABLE WAS NOT FLEXED NOR EXTENDED DURING THE CASE. AFTER THE CASE THERE WAS REDNESS THAT RESULTED IN A PRESSURE ULCER ON THE PATIENT'S CHEST.

    Patient problems: Pressure Sore/Ulcer

    MAUDE report 9606683 ↗

Other Table, Surgical With Orthopedic Accessories, Ac-Powered devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.