MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE GENERATOR; ELECTROSURGICAL SYSTEM GENERATOR

Catalog Number 225024

Device Problem Intermittent Continuity (1121)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Neither the fault reported by the customer could be verified nor another fault was found.The following activities were performed unit cleaned, 1hr.- output power test completed, unit calibrated newly, by built-in-test (bite) indicated fault codes analysed, functional test performed, electrical safety test acc.To iec 60601-1 completed, functional test acc.To test procedure completed, and safety test checklist enclosed.A review into the depuy synthes mitek complaints system revealed no other complaints for this device's serial number.At this point in time, no corrective action is required and no further action is warranted.A device history record review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported the vapr vue generator connection with the vpr coolpulse 90 electrode does not work lot.The connection is causing breaks in the electrode function stalling the surgery.No information was provided regarding the surgical procedure or status of patient.This is report 1 of 2 for (b)(4).

• Brand Name: VAPR VUE GENERATOR
• Type of Device: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 8282072
• MDR Text Key: 135527306
• Report Number: 1221934-2018-53829
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009121
• UDI-Public: 10886705009121
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 225024
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 01/28/2019
• Date Device Manufactured: 07/16/2014
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1