MAUDE Adverse Event Report: ANGIODYNAMICS TALON 25CM SEMIFLEX; ELECTROSURGICAL PROBE

Catalog Number	H7877001028451
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.The firm is attempting to obtain the device.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
As reported to angiodynamics on (b)(6) 2017: during a ct guided liver ablation procedure, when withdrawing the probe in order to place for a second ablation, it was noted the shaft of the probe had bent and cracked open.The device was set aside and a new of the same was used to successfully complete the procedure.There was no harm or injury to the patient due to this event.It was reported that the device involved in the incident is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Returned for evaluation was a starburst talon probe.A visual review of the device noted that at 2.7 cm from the handle, the trocar is fractured in the "no bend" area.The customer's reported complaint description of a broken probe is confirmed.A device history records search revealed no quality related issues or manufacturing deficiencies at the time of manufacture.The ifu instructs the user not to bend the trocar smaller than a radius of approximately 5 cm.Additionally, the site of the fracture is in the "no bend area" of the trocar.The most likely root cause to this complaint is due to physical force placed upon the trocar shaft during the procedure.Although this root cause cannot be definitively determined, this event does not appear a result of any manufacturing anomalies.The instruction for use, which is supplied to the user with this catalog number contains the following statement: the device can bend to a radius of approximately 5 cm.For semiflex talons: over bending of the trocar to a radius smaller than 5 cm beyond a 90° curvature and/or kinking the device can damage the trocar and cause patient injury.Do not bend or kink the trocar or the needles.This may cause damage and result in a non-functional device.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: TALON 25CM SEMIFLEX
• Common Device Name: ELECTROSURGICAL PROBE
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 6833593
• Report Number: 1056436-2017-00100
• Device Sequence Number: 65715
• Product Code: GEI
• UDI-Device Identifier: H7877001028451
• UDI-Public: H7877001028451
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: Physician
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: H7877001028451
• Device Lot Number: 5116738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 08/14/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1