MAUDE Adverse Event Report: ATRICURE INC. ISOLATOR TRANSPOLAR PEN; ISOLATOR TT LONG PEN

Model Number MAX5

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the device was returned for evaluation and visually and functionally tested pursuant to form-099.C.Upon inspection the lateral side of one electrode was exposed due to a missing piece of abs insulator.The distal insulator abs portion was not properly aligned and mated to the overmold body.It was determined the end effector delaminated from electrode.This mdr is filed as a result of an internal retroactive review.

Event Description

It was reported during a procedure a small piece of the tip of the max5 pen had broken off during surgery.The procedure was delayed for five minutes while a second device was unpacked and used.The patient was off pump.

• Brand Name: ISOLATOR TRANSPOLAR PEN
• Type of Device: ISOLATOR TT LONG PEN
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6336255
• MDR Text Key: 67598211
• Report Number: 3003502395-2017-00026
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K061593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/01/2018
• Device Model Number: MAX5
• Device Catalogue Number: A000625-EU
• Device Lot Number: 58709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2015
• 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