MAUDE Adverse Event Report: ANGIODYNAMICS PMTA ACCU2I STANDARD APPLICATOR; MICROWAVE APPLICATOR

Catalog Number 900-600

Device Problem Material Separation (1562)

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

Event Date 12/09/2013

Event Type  Injury  

Event Description

As reported on (b)(6) 2013, pt of unk age and gender presented for an microwave procedure of the liver.At the conclusion of the procedure, when the probe was withdrawn, it was noted the tip of the applicator had partially came away from the probe shaft.The tip did not detach or separate from the body of the probe.The procedure had been successfully completed with this device with no report of pt complications, harm or injury.The disposable device has been returned to the manufacturer for eval.

Manufacturer Narrative

The reported defect device has been returned to the manufacturer.An investigation into the root cause of this incident is currently in progress.The results of the investigation and any follow up info will be sent via a follow up medwatch.A review of the lot history records for the reported lot was performed for any deviations.The review confirms that the lots met all material, assembly, and performance specifications.(b)(4).

• Brand Name: PMTA ACCU2I STANDARD APPLICATOR
• Type of Device: MICROWAVE APPLICATOR
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury ave.; queensbury NY 12804
• Manufacturer Contact: dan anderson ; 603 queensbury ave.; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 3597177
• MDR Text Key: 4067929
• Report Number: 1319211-2014-00001
• Device Sequence Number: 1
• Product Code: NEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 900-600
• Device Lot Number: 13420208
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/30/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2013
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention