MAUDE Adverse Event Report: ANGIODYNAMICS, INC. VENACURE EVLT; POWERED LASER SURGICAL INSTRUMENT

Model Number	11403001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: laser fiber being used in ablation case was fractured and burned a hole through the sterile drapes on the field.Prior to all safety measures were being followed per protocol.The event happened due to a faulty product and could not have been predicted due to the nature of the product.

• Brand Name: VENACURE EVLT
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ANGIODYNAMICS, INC.; 26 forest st.; marlborough MA 01752
• MDR Report Key: 22792212
• Report Number: 22792212
• Device Sequence Number: 8314993
• Product Code: GEX
• UDI-Device Identifier: 15051684014489
• UDI-Public: (01)15051684014489
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2025
• Report Date (Section F): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11403001
• Device Catalogue Number: 11403001
• Device Lot Number: 5841563
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Date Report Sent to FDA: 08/05/2025