MAUDE Adverse Event Report: ANGIODYNAMICS, INC NANOKNIFE SYSTEM; LOW ENERGY DIRECT CURRENT ABLATION SYSTEM

Model Number 20300301

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the nanoknife system (sn (b)(4)) involved in the incident is available to be returned to the manufacturer for evaluation.The results of the unit evaluation will be sent via a follow up medwatch.Complaint (b)(4).

Event Description

An distributor reported the end user was experiencing an ire keyboard failure.When certain keys are pressed, the result is different letters and symbols than requested.The system has been rebooted several times with no improvement.The procedure was aborted due to this event and there was no patient harm or adverse event reported by the end user.As the patient was sedated and treatment was not provided, this report meets the criterai of a reportable adverse event.It was reported that the patient suffered no adverse effects due to the event.The customer has requested the facility's unit be evaluated by the manufacturer.The unit has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Based on additional information and assessment of the returned nanoknife unit, this reported event was determined to no longer meet the criteria of a reportable event.This report is being submitted in order to close out the file.Complaint (b)(4).

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LOW ENERGY DIRECT CURRENT ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury, ny
• MDR Report Key: 10184368
• MDR Text Key: 196098152
• Report Number: 1319211-2020-00040
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• PMA/PMN Number: K102329
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Date Manufacturer Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1