Arthrex® AR-3240-5027Recalls & reported problems
Arthrex, Inc. · Fused Light Cable, 5.0 mm x 274cm (9.0') · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Arthrex fused fiberoptic light cable is used to illuminate the inside of the body during surgery. Most of the 30 reports describe the cable getting very hot during procedures, sometimes smoking, melting, fraying or showing exposed wires, and a few mention first- or second-degree burns. There are 3 injuries and no deaths. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00888867029408), received between Jul 1, 2020 and Jun 20, 2024 — classified as 3 injuries, 27 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (19 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device19
- Excessive Heating4
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Material Frayed1
- Melted1
- Optical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Superficial (First Degree) Burn3
- Burn, Thermal2
- Insufficient Information2
- Discomfort1
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 20, 2024Material Frayed; Material Frayed
ON 12/09/2022 IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-3240-5027 HAS EXPOSED WIRES. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19574999 ↗MalfunctionJun 18, 2024Excessive Heating; Excessive Heating
ON 10/14/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A AR-3240-5027 FUSED LIGHT CABLE IS GETTING REALLY HOT DURING PROCEDURES. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19563392 ↗MalfunctionJun 18, 2024Overheating of Device; Overheating of Device
ON 01/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT DURING AN LAPAROSCOPIC PROCEDURE ON (B)(6) 2022, THE DISTAL TIP OF THE AR-3352-5530 LAPAROSCOPE BECAME HOT AND BURNED A HOLE IN THE DRAPE. THE SURGEON USED A BLUE CLOTH TO COVER THE BURNED DRAPE. THE PATIENT WAS NOT HARMED AND THE CASE WAS COMPLETED BY TURNING OFF THE SCOPE AND AFTER A FEW MINUTES THEY WERE ABLE TO COMPLETE THE CASE USING THE SAME SCOPE. THE SALES REPRESENTATIVE WAS NOT PRESENT DURING THIS CASE AND UPON ARRIVAL THE 1/21/2022, WAS ABLE TO COLLECT THE DEVICE(S) USED IN THE CASE FOR EVALUATION. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION PROVIDED 1/24/2022: ALL PART AND SERIAL NUMBERS WERE PROVIDED. AN IMAGE OF THE DRAPE IS ALSO ATTACHED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19561289 ↗MalfunctionJun 18, 2024Break; Break
ON 03/03/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA SEMS THAT AR-3240-5027 LIGHT GUIDES FIBER OPTIC CABLES ARE BROKEN AND THE DEVICE IS HEATING UP. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560796 ↗MalfunctionJun 18, 2024Overheating of Device; Overheating of Device
ON 4/7/2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3240-5027 FUSED LIGHT CABLE WAS OVERHEATING AND NOT WORKING CORRECTLY. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19560133 ↗MalfunctionJun 18, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE AR-3240-5027 GOT TOO HOT DURING A CX PROCEDURE FOR THE SURGEON'S COMFORT.
Patient problems: Discomfort
MAUDE report 19559189 ↗MalfunctionJun 12, 2024Overheating of Device; Overheating of Device
ON 11/22/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3240-5027 FUSED LIGHT CABLE WAS HEATING UP AT THE CONNECTION POINT WHEN IN USE. THIS WAS DISCOVERED DURING A PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19522149 ↗MalfunctionJun 12, 2024Overheating of Device; Overheating of Device
ON 11/14/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3240-5027 LIGHT CABLE IS OVERHEATING. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19522030 ↗MalfunctionJun 12, 2024Overheating of Device; Overheating of Device
ON 10/25/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3240-5027 FUSED LIGHT CABLE WAS GETTING REALLY HOT AND GIVING A BURNING SMELL. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19520155 ↗MalfunctionJun 12, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING A PROCEDURE, THE AR-3240-5027, CABLE BECAME VERY HOT AND MELTED. THE CASE WAS COMPLETE BY USING A NEW AR-3240-5027 WITHOUT FURTHER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19519751 ↗MalfunctionJun 11, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE AR-3240-5027, LIGHT CORD BECAME SO HOT TO THE TOUCH, THAT THEY FINISHED THE CASE WITH A DIFFERENT LIGHT CORD. NO ADVERSE EFFECT TO THE PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508946 ↗MalfunctionJun 11, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE THE AR-3240-5027 LIGHT CORD IS OVERHEATING AND GETTING HOT TO THE TOUCH AND IS ALSO VERY DIM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508909 ↗MalfunctionJun 9, 2024Excessive Heating; Excessive Heating
ON 04/11/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA SEMS THAT A AR-3240-5027 FUSED LIGHT CABLE IS BURNT. THIS WAS DISCOVERED ON 04/09/2022 DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19495222 ↗MalfunctionJun 3, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT THE AR-3240-5027 GOT TOO HOT DURING A CX PROCEDURE FOR THE SURGEON'S DISCOMFORT.
Patient problems: Insufficient Information
MAUDE report 19450920 ↗MalfunctionMay 24, 2024Overheating of Device; Overheating of Device
ON 06/21/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3240-5027 FUSED LIGHT CABLE WAS OVERHEATING DURING AN UNSPECIFIED PROCEDURE, NO PATIENT WAS AFFECTED. THIS WAS DISCOVERED DURING USE WITH NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391091 ↗MalfunctionMay 24, 2024Overheating of Device; Overheating of Device
ON 07/05/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT THE AR-3240-5027 FUSED LIGHT CABLE END THAT PLUGS INTO THE CAMERA IS GETTING HOT. THIS WAS DISCOVERED DURING AN UNSPECIFIED PROCEDURE, WITH NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19390808 ↗MalfunctionMay 23, 2024Overheating of Device; Overheating of Device
ON 01/06/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-3240-5027 LIGHT CABLE WAS HOT TO THE TOUCH. THIS WAS DISCOVERED DURING USE IN PROCEDURE. THE CASE WAS COMPLETED BY SWAPPING OUT THE LIGHT CABLE. ADDITIONAL INFORMATION 1/13/2021 ON 01/13/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE PART OF THE AR-3240-5027 LIGHT CABLE THAT ATTACHES TO THE SCOPE WAS HOT TO THE TOUCH. THIS WAS DISCOVERED DURING USE IN A SHOULDER PROCEDURE ON (B)(6) 2022. THE CASE WAS COMPLETED BY SWAPPING OUT THE LIGHT CABLE. THE CASE WAS COMPLETED BY SWAPPING OUT THE LIGHT CABLE, NO INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19381277 ↗MalfunctionMay 22, 2024Excessive Heating; Excessive Heating
IT WAS REPORTED THAT THE APPROACH IS BURNT. THERE WAS NO HARM FOR THE PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19369337 ↗MalfunctionMay 20, 2024Optical Problem; Optical Problem
IT WAS REPORTED THAT THE LIGHT GUIDE CABLE IS BURNED THROUGH ON THE SIDE WHERE THE OPTICS ARE CONNECTED. THERE IS NO DAMAGE TO THE OPTICS ITSELF. THE PROBLEM WAS NOTICED AFTER THE SURGERY/ TREATMENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19354458 ↗MalfunctionMay 20, 2024Overheating of Device; Overheating of Device
ON 10/05/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3240-5027 LIGHT CORD, WAS OVERHEATING. THIS WAS DISCOVERED DURING USE IN A PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19351084 ↗MalfunctionMay 14, 2024Overheating of Device; Overheating of Device
ON 04/22/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT A AR-3240-5027 FUSED LIGHT CABLE IS OVERHITTING. THIS OCCURRED DURING AN UNKNOWN CASE, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19309898 ↗MalfunctionApr 26, 2024Overheating of Device; Overheating of Device
IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY PERFORMED BY DR. PAE ON 07/13/2021, THE LIGHT LEVEL FROM THE CABLE FADED WHEN THE CABLE BECAME HEATED. THE PROCEDURE WAS COMPLETED USING A NEW CABLE OF THE SAME PART NUMBER WITH NO PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19191711 ↗InjuryNov 17, 2023Overheating of Device; Overheating of Device
ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-3200-0001T CONSOLES MONITOR WENT DARK AND THE FIBER WAS HOT. THIS OCCURRED DURING AN ARTHROSCOPIC PATELLAR DISLOCATION PLASTY PROCEDURE ON (B)(6) 2023, WHERE THE PATIENT HAD A SHALLOW SECOND-DEGREE SKIN SCALD WITH AN AREA OF ABOUT 1*0.5 CM AND ULCERATION IN THE ANTERIOR UPPER TIBIAL SEGMENT OF THE LEFT CALF. THERE ARE ALSO TWO DEEP SECOND-DEGREE SKIN SCALDS AND RUPTURING IN THE MIDDLE AND UPPER SEGMENTS, ONE WITH AN AREA OF 1*0.5CM AND THE OTHER WITH AN AREA OF 2*2 CM. THE WOUNDS WERE CAUSED BY HEAT BURNING IN THE FIBER. THE CASE WAS COMPLETED SEVERAL HOURS LATER.
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 18163231 ↗MalfunctionSep 6, 2022Smoking
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT (2) AR-3240-5027 FUSED LIGHT CABLES IS SMOKING WHEN PLUGGED IN, THIS OCCURRED DURING AN UNKNOWN TIME AND WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15362657 ↗MalfunctionJun 13, 2022Melted
ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT A SURGEON WAS HOLDING A LIGHT CORD AS IT MELTED THROUGH THE SURGEON'S GOWN AND PARTIALLY INTO THE LEAD VEST UNDERNEATH. THIS WAS DISCOVERED DURING A PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THIS WAS DISCOVERED DURING A LEFT EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY POSSIBLE CYSTOSCOPY RETROGRADE PYELOGRAM ON (B)(6) 2022. THERE WAS NOT HARM TO PATIENT NOR THE SURGEON, AS THE ISSUE WAS NOTICED WHEN THE CASE WAS COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14674378 ↗
Other LIGHT, SURGICAL, FIBEROPTIC devices
- NA 242386Medos International Sàrl · LIGHT, SURGICAL, FIBEROPTIC49 reports
- Integra® 001388LX9Integra Lifesciences (Ireland) Limited · LIGHT, SURGICAL, FIBEROPTIC7 reports
- N/A FC1SPStryker Corporation · Light, Surgical, Fiberoptic5 reports
- UltraLite® AX2100BIFIntegra Lifesciences (Ireland) Limited · LIGHT, SURGICAL, FIBEROPTIC4 reports
- NA 242387Medos International Sàrl · LIGHT, SURGICAL, FIBEROPTIC3 reports
- Arthrex® AR-3240-5040Arthrex, Inc. · LIGHT, SURGICAL, FIBEROPTIC3 reports
- LITe DECOMPRESSION 48089999Stryker Corporation · LIGHT, SURGICAL, FIBEROPTIC2 reports
- MaXcess 3200220Nuvasive, Inc. · LIGHT, SURGICAL, FIBEROPTIC2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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