MAUDE Adverse Event Report: ANGIODYNAMICS NANOKNIFE SYSTEM; LECD THERMAL ABLATION SYSTEM

Model Number 20300101

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2014

Event Type  malfunction  

Event Description

As reported on (b)(6) 2014, pt of unk gender and age presented for a lecd thermal ablation.During the procedure, it was reported the nanoknife unit experienced a hardware communication error message, shutting the unit down.The unit was rebooted several times, and the procedure was successfully completed using this same unit.However due to the extended delay during the procedure, the pt was administered additional medication.It was reported the pt suffered no harm or injury due to the event.It was reported the nanoknife system is available for return for evaluation to the mfr.

Manufacturer Narrative

It was reported that the device involved in the incident is available to be returned to the mfr for evaluation.To date, the device has yet to be returned.Attempts are being made to obtain the device.An investigation into the root cause for event is currently in progress.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.The results of the unit evaluation will be sent via a follow up medwatch.(b)(4).

Manufacturer Narrative

The ire generator (serial number (b)(4)) received field service by an angiodynamics' field service engineer.No defects of the generator were noted during initial assessment.Functional assessment was performed on the unit.The unit met all acceptance criteria.There was no report of harm or injury to the patient due to the procedure being prolonged.The reported complaint description could not be confirmed as the unit functioned as intended during testing and no errors were found in the log files.A root cause for the complaint description could not be determined as no defects were found with the generator.A review of the device history records was performed for the serial number (b)(4).The review confirms that the unit met all material, assembly, and performance specifications.The user manual, provided to the user with the system instructs the user on how to troubleshoot when the generator fails self-testing as well as unit shut down issues.The catalog and lot number of the disposable probe used during the event was not reported by the user.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.

• Brand Name: NANOKNIFE SYSTEM
• Type of Device: LECD THERMAL ABLATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 3881761
• MDR Text Key: 4591632
• Report Number: 1319211-2014-00069
• Device Sequence Number: 1
• Product Code: OAB
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K080376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20300101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1