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Y/C cable MB-631Recalls & reported problems

Olympus Medical Systems Corp. · "MB-631 ISOLATION TRANSFORMER" · Class 2

Adverse event reports
5
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170026669), received between Jan 20, 2021 and Sep 30, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break2
  • Fire1
  • Sparking1
  • Unintended Electrical Shock1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2024Unintended Electrical Shock; Unintended Electrical Shock

    IT WAS REPORTED THE TRANSFORMER POWER CORD BROKE AND SPARKS OCCURRED. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO HEALTH HAZARDS WERE REPORTED AS A RESULT OF THIS INCIDENT. THERE WERE NO REPORTS OF PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20335400 ↗
  • MalfunctionDec 28, 2023Sparking; Sparking

    THE CUSTOMER REPORTED TO OLYMPUS THAT WHILE PREPARING FOR THE UNSPECIFIED PROCEDURE, THE TRANSFORMER WAS CONNECTED TO AN ELECTRICAL OUTLET, AND SHORTLY AFTER THAT, SPARKS APPEARED FROM THE ELECTRICAL OUTLET. THE STRESS WAS PLACED ON THE OREDOME PART OF THE CABLE, CAUSING IT TO SPLIT AND THE WIRING INSIDE TO BREAK. THE INTENDED PROCEDURE WAS COMPLETED BY CHANGING THE OUTLET. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18409066 ↗
  • MalfunctionJul 8, 2022Break; Break

    AS REPORTED FOR THIS EVENT BY THE CUSTOMER, AFTER AN INSPECTION OF THE DEVICE WAS PERFORMED, THE DEVICE PLUG BROKE UPON UNPLUGGING FROM THE SOCKET. THERE WAS A BURN MARK ON THE SURFACE. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14959633 ↗
  • MalfunctionApr 30, 2021Fire; Fire

    THE USER USED THE OTV-S7 (THE VIDEO SYSTEM CENTER), CLV-S40 (LIGHT SOURCE), A MONITOR (THE MODEL NUMBER WAS UNKNOWN), AND THIS MB-631 (AN ISOLATION TRANSFORMER). THE USER CONNECTED MB-631 FROM A WALL OUTLET VIA AN EXTENSION CORD. NO OTHER DEVICE WAS CONNECTED TO THE EXTENSION CORD. THE USER FOUND THAT THE PLUG OF MB-631 WAS BURNT. IT IS UNKNOWN IF THE POWER OF THESE DEVICES WAS TURNED ON WHEN THE EVENT OCCURRED. IT IS UNKNOWN WHETHER THE DEVICE SPARKED OR THE FIRE WENT UP. AFTER THIS EVENT, THE DEVICE COULD BE USED WITHOUT ANY PROBLEMS. THERE WERE NO REPORTS OF PATIENT INJURIES RELATED TO THIS INCIDENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11751187 ↗
  • MalfunctionJan 20, 2021Break; Break

    OLYMPUS SERVICE OPERATION REPAIR CENTER WAS INFORMED FROM THE FACILITY THAT IN UNSPECIFIED TIMING THE POWER CORD OF THE DEVICE WAS BROKEN. OTHER DETAILED INFORMATION WAS NOT PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11200103 ↗

Other Transformer, Endoscope 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.