Olympus A0393Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · HF-cable, monopolar, 4 m, UES-30/-40, Erbe Intl. and Valleylab (new) HF-unit to resectoscope · Class 2
Quick summary
This Olympus monopolar HF cable is an electrical cable that connects a high-frequency surgical unit to a resectoscope. Its 99 adverse event reports include no deaths, 5 injuries and 94 malfunctions. The reports mostly describe sparking, cracking or breaking, and burnt or charred cords, with some describing fire or smoke. Some reports describe burns to patients. No recalls name this device.
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
- 100
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 100 adverse event reports that list this exact device (DI 04042761001656), received between May 10, 2018 and Sep 14, 2026 — classified as 5 injuries, 95 malfunctions.
The most frequently reported specific device problem is “Sparking” (57 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
- Sparking57
- Break22
- Fire18
- Arcing11
- Smoking10
- Thermal Decomposition of Device7
- Material Split, Cut or Torn5
- Electrical /Electronic Property Problem4
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Known Impact Or Consequence To Patient12
- No Consequences Or Impact To Patient8
- Burn(s)3
- Burn, Thermal1
- Electric Shock1
- No Information1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 100 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Sparking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764210 ↗MalfunctionJun 18, 2026Overheating of Device
THE CUSTOMER RETURNED THE ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, CHARRED STAINS WERE OBSERVED AROUND THE CABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25546849 ↗MalfunctionMay 19, 2026Fire
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25215886 ↗MalfunctionMay 13, 2026Thermal Decomposition of Device; Material Separation
IT WAS REPORTED THE ELECTRICAL ONLY MEDICAL DEVICE CONNECTION CABLE; REUSABLE HAD A CORD BURNT AND WAS SEPARATED FROM THE PLUG AT THE CAUTERY MACHINE END. THE ISSUE WAS FOUND DURING A TRANSURETHRAL RESECTION OF PROSTATE GLAND PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25160194 ↗MalfunctionFeb 9, 2026Break; Sparking
IT WAS REPORTED THE ELECTRICAL-ONLY MEDICAL DEVICE CONNECTION CABLE, REUSABLE EXHIBITED CABLE SPARKED AND BROKE. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24300849 ↗MalfunctionJan 30, 2026Sparking
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24221504 ↗MalfunctionJan 8, 2026Electrical /Electronic Property Problem
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24006155 ↗MalfunctionJan 8, 2026Electrical /Electronic Property Problem
IT WAS REPORTED THAT THE MONOPOLAR CABLE HAD ELECTRODE LOOP FAILURE FOLLOWED BY LOUD POP AND SEVERED CORD. THE ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005697 ↗MalfunctionOct 24, 2025Sparking; Detachment of Device or Device Component; Sparking; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379425 ↗MalfunctionMar 27, 2025Break; Sparking; Explosion; Break; Sparking; Explosion
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD ISSUES WITH THE CAUTERY PEDAL, PRODUCING A LOUD SNAP AND SPARKS, AND THE CAUTERY CORD BLEW APART AT THE HUB. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21710981 ↗MalfunctionFeb 25, 2025Fire; Fire
IT WAS REPORTED THAT THE¿GENERATOR'S CORD CAUGHT FIRE. ¿THE ISSUE WAS FOUND DURING A THERAPEUTIC TRANSURETHRAL RESECTION (TUR) PROCEDURE THAT WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WAS A PROCEDURAL DELAY DURING SEDATION FOR LESS THAN 30 MINUTES, BUT THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21461044 ↗MalfunctionJan 7, 2025Sparking; Sparking
IT WAS REPORTED THAT THE GENERATOR HAD A SPARK WHEN THE MONOPOLAR CABLE WAS DISCONNECTED. THE EVENT OCCURRED DURING SET UP FOR A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21094054 ↗MalfunctionOct 23, 2024Break; Sparking; Break; Sparking
IT WAS REPORTED THE MONOPOLAR HIGH FREQUENCY CABLE SPARKED AND THEN SEPARATED. A SIMILAR PRODUCT WAS USED FOR THE REMAINDER OF THE CASE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20517204 ↗MalfunctionOct 22, 2024Break; Sparking; Break; Sparking
IT WAS REPORTED, THE MONOPOLAR HIGH FREQUENCY CABLE SPARKED AND SNAPPED OFF AT THE JUNCTION POINT. WHERE THE CORD HOOKS ONTO THE RESECTOSCOPE. THE ISSUE OCCURRED, DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20508800 ↗MalfunctionSep 30, 2024Break; Fire; Sparking; Break; Fire; Sparking
IT WAS REPORTED THE MONOPOLAR CABLE OF THE ELECTROSURGICAL GENERATOR SPARKED AND CAUGHT ON FIRE. THE ISSUE OCCURRED DURING A THERAPEUTIC, TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333205 ↗MalfunctionSep 9, 2024Sparking; Sparking
IT WAS REPORTED THAT WHEN TRYING TO USE THE MEDICAL DEVICE CONNECTION CABLE, IT SPARKED. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20169622 ↗MalfunctionSep 6, 2024Sparking; Sparking
IT WAS REPORTED THE CONNECTION CABLE HAD A SPARK FROM THE RESECTOSCOPE OF THE CAUTERY CORD. THE SURGEON¿S HAND WAS HIT BY THE SPARK AND NEEDED TO CHANGE SURGICAL GLOVES AFTER THE INCIDENT. THE ISSUE OCCURRED DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20157889 ↗MalfunctionJun 28, 2024Fire; Fire
IT WAS REPORTED THE ELECTRICAL CONNECTION CABLE SPARKED AND CAUGHT ON FIRE. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19633459 ↗MalfunctionMay 17, 2024Sparking; Sparking
IT WAS REPORTED THAT AT THE END OF A DIAGNOSTIC HYSTEROSCOPY PROCEDURE, INCREASING THE CORE OUTPUT SETTING FROM 30 TO 70 CAUSED SPARKS TO FLY, CUTTING OFF PART OF THE INSERTION PORT FROM THE HIGH FREQUENCY-CABLE. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER DEVICE, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19343179 ↗MalfunctionApr 5, 2024Disconnection; Sparking; Disconnection; Sparking
THE ISSUE OCCURRED DURING A DIAGNOSTIC ESOPHAGOGASTRODUODENOSCOPY PROCEDURE AND AN ERROR MESSAGE OF CV MALFUNCTION - CONTACT OLYMPUS (B40) WAS DISPLAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055581 ↗MalfunctionFeb 12, 2024Thermal Decomposition of Device; Thermal Decomposition of Device
IT WAS REPORTED THAT WHILE PERFORMING THE TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, WHEN THE HIGH-FREQUENCY MONOPOLAR CABLE'S CAUTERY WAS ACTIVATED, THERE WAS A SPARK, AND THE CORD BROKE APART WITH A PUFF OF SMOKE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE DEVICE ISSUE DID NOT IMPACT THE OUTCOME OF THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18692124 ↗MalfunctionDec 9, 2023Break; Fire; Smoking; Sparking; Break; Fire; Smoking; Sparking
THE CUSTOMER REPORTED TO OLYMPUS, THE CABLE BROKE, THE HIGH FREQUENCY CABLE MADE A POPPING SOUND, THEN SPARKED. THE ISSUE WAS FOUND DURING A TRANS URETHRAL RESECTION OF BLADDER TUMOR PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THE PROCEDURE WAS DELAYED BY 5 MINUTES. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18298353 ↗MalfunctionDec 7, 2023Break; Sparking; Break; Sparking
THE DEVICE MALFUNCTION WAS FIRST NOTICED AT THE BEGINNING OF A THERAPEUTIC TURBT (TRANSURETHRAL RESECTION BLADDER TUMOR) PROCEDURE. A FIVE MINUTE DELAY OCCURRED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. NO ERROR MESSAGES OBSERVED DUE TO THE DEVICE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18285386 ↗MalfunctionNov 15, 2023Output Problem; Output Problem
THE CUSTOMER REPORTED THAT THE CABLE HAD POOR PERFORMANCE. THE ISSUE WAS FOUND DURING AN UNSPECIFIED PROCEDURE. THIS WAS THE SECOND CABLE TO FAIL IN THE PROCEDURE. THERE WERE NO REPORTS OF HARM. THIS REPORT IS RELATED TO LINKED PATIENT IDENTIFIER (B)(6), FOR THE OTHER FAILED CABLE IN THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18138486 ↗MalfunctionNov 13, 2023Sparking; Sparking
THE CUSTOMER REPORTED THAT THE MONOPOLAR CABLE MADE A POPPING NOISE AND COULD NO LONGER BE USED IN THE PROCEDURE. THERE WERE NO REPORTS OF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18120010 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.