MAUDE Adverse Event Report: ANGIODYNAMICS, INC NANOKNIFE SINGLE ELECTRODE PROBE, 15CM; IRREVERSIBLE ELECTROPORATION SYSTEM

Catalog Number	H787204001040
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device involved in the incident is available to be returned to the manufacturer 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 incident is currently in progress.The results of the investigation will be sent via a follow up medwatch.Complaint reference (b)(4).
Event or Problem Description
A patient of unknown age and gender presented for an ire procedure via perineum access.It was reported that when attempting to insert the probe, a piece of the insulation sleeve broke off.As the insulation sleeve fractured outside of the patient, there was no patient harm or injury.It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information provided determined the insulation sleeves did not fracture off inside of the patient as originally reported.This complaint has been reassessed as not meeting the criteria of a reportable adverse event.This medwatch is being submitted in order to close out t he complaint record.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Complaint reference (b)(4).

• Brand Name: NANOKNIFE SINGLE ELECTRODE PROBE, 15CM
• Common Device Name: IRREVERSIBLE ELECTROPORATION SYSTEM
• Manufacturer (Section D): ANGIODYNAMICS, INC; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 8286808
• Report Number: 1319211-2019-00020
• Device Sequence Number: 2081729
• Product Code: GEI
• UDI-Device Identifier: H787204001040
• UDI-Public: H787204001040
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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 Catalogue Number: H787204001040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1