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

Model Number 225024

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Not Applicable (3189)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (b)(4).

Event Description

It was reported by affiliate via mail, the vapr vue generator.During surgery, the vaporizer and coagulation don¿t work correctly.There was a delay of 10 minutes.The device is available to be returned for evaluation.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary
=
> the device was received and evaluated at the service center.The reported complaint that the vaporizer and coagulation of the device doesn¿t work correctly, was confirmed.It was found that 8 pin socket was corroded by fluid.Further, the front panel was physically damaged and the hand switch led was damaged.The tamper-proof seal was also found to be damaged.The software of the device was modified, the device was newly calibrated, the damaged connector replaced along with the damaged front panel, and the device was cleaned, tested, and found to be fully functional.Fluid ingress into the device is the root cause of the corrosion of the 8-way socket connector.Further, user mishandling may have most probably caused the damage to the front panel and the hand switch led.A manufacturing record evaluation was performed for the finished device [serial number ; (b)(6)], and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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.

• Brand Name: VAPR VUE GENERATOR
• Type of Device: ELECTROSURGICAL SYSTEM GENERATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10381302
• MDR Text Key: 202218540
• Report Number: 1221934-2020-02039
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10886705009121
• UDI-Public: 10886705009121
• Combination Product (y/n): N
• PMA/PMN Number: K113545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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 Model Number: 225024
• Device Catalogue Number: 225024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 08/29/2020
• Supplement Dates FDA Received: 08/31/2020
• Patient Sequence Number: 1