FUSION-DESIGN 80663530Recalls & reported problems
Richard Wolf GmbH · FIBER LIGHT CABLE Ø 3.5MM TL 3M color code orange · 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 04055207026359), received between Apr 30, 2025 and Apr 30, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Temperature 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
- Temperature Problem1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 30, 2025Temperature Problem; Temperature Problem
ACCORDING TO THE INFORMATION RECEIVED, THE CONNECTION WHERE THE LIGHT CABLE ATTACHES TO THE ENDOSCOPE BECAME VERY HOT AND BURNED THE SURGEON'S HAND.
Patient problems: Burn(s)
MAUDE report 21938180 ↗
Other ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) devices
- NA 242437Medos International Sàrl · ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)191 reports
- 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.