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

Catalog Number 900-602

Device Problem Bent (1059)

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

Event Date 03/24/2015

Event Type  Injury  

Event Description

As reported (b)(6) 2015, a pt of unk age and gender presented for an microwave procedure.During prep for the procedure, when opening the sterile package, it was noted the tip of the applicator was slightly bent.As a precaution, the device was set aside and a new of the same device was used to successfully complete the procedure.It was reported the pt suffered no harm or injury due to the event as the device did not come into contact with the pt.It was reported the disposable device is available for return to the mfr for eval.

Manufacturer Narrative

It was reported that the device involved in the incident is available to be returned to the mfr for eval.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.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 spec.The results of the device eval will be sent via a f/u medwatch.Complaint # (b)(4).

• Brand Name: PMTA ACCU2I INTERMEDIATE APPLICATOR
• Type of Device: MICROWAVE APPLICATOR
• 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: 4707682
• MDR Text Key: 16558531
• Report Number: 1319211-2015-00235
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Catalogue Number: 900-602
• Device Lot Number: 14480329
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• 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