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
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
- Welch Allyn, Inc. 901027Welch Allyn, Inc. · TRANSFORMER, ENDOSCOPE1 recall0 reports
- Welch Allyn, Inc. 901027Welch Allyn, Inc. · TRANSFORMER, ENDOSCOPE1 recall0 reports
- Welch Allyn, Inc. 901027Welch Allyn, Inc. · Transformer, endoscope2 reports
- Welch Allyn, Inc. 901027Welch Allyn, Inc. · Transformer, endoscope2 reports
- Welch Allyn, Inc. 901067Welch Allyn, Inc. · Transformer, endoscope2 reports
- Welch Allyn, Inc. 901027Welch Allyn, Inc. · TRANSFORMER, ENDOSCOPE1 report
- Welch Allyn, Inc. 901067Welch Allyn, Inc. · Transformer, endoscope1 report
- Welch Allyn, Inc. 901067Welch Allyn, Inc. · Transformer, endoscope1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.