FUSION 80655030Recalls & reported problems
Richard Wolf GmbH · FIBER LIGHT CABLE Ø 5MM TL 3M temperature stable, color code gray · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207026250), received between Jul 8, 2026 and Jul 8, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Full thickness (Third Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 8, 2026Use of Device Problem
THE USER REPORTED THAT, THE PRODUCT BECAME EXCESSIVELY HOT, CAUSING A THIRD-DEGREE THERMAL BURN TO THE PATIENT'S GLANS. AFTER THE PROCEDURE WAS COMPLETED, THE DOCTOR LEFT THE URETERO-RENOSCOPE ON THE PATIENT WHILE THE ENDOLIGHT LED 2.2 REMAINED TURNED ON, WITH THE LIGHT FIBER CABLE AND THE URETERO-RENOSCOPE STILL CONNECTED, CONTRIBUTING TO THE REPORTED INCIDENT.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 25751747 ↗
Other ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) devices
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- Ambu aView™ 2 Advance 405011000Ambu A/S · ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)2 recalls4 reports
- NA 242436Medos International Sàrl · ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)67 reports
- NA 242435Medos International Sàrl · ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)37 reports
- NA 242316Medos International Sàrl · ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)10 reports
- Olympus WM-NP2Keymed (Medical & Industrial Equipment) Limited · Accessories, Photographic, For Endoscope (Exclude Light Sources)4 reports
- Olympus WM-DP2Keymed (Medical & Industrial Equipment) Limited · Accessories, Photographic, For Endoscope (Exclude Light Sources)3 reports
- Olympus TC-L Compact Trolley Set 1Keymed (Medical & Industrial Equipment) Limited · Accessories, Photographic, For Endoscope (Exclude Light Sources)2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.