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

Model Number 225024

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device was received at the service center and evaluated.It was reported that the screen was cracked.Per service reports, this complaint cannot be confirmed.During the service evaluation the following defects were identified: base plate damaged.Seal damaged.Fan broken.8 pin socket corroded by fluid.Blue up button sometimes without function - intermittent operation.Moisture damage.The front panel and assembly were replaced to resolve the issues.After repair, the device was found to be working according to the specifications.The faulty parts was identified as the root cause for the device failure during the service evaluation.Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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.

Event Description

It was reported by the affiliate in (b)(6) that the screen on the vapr vue generator device was cracked.During in-house engineering evaluation, it was determined that the fan was broken, the 8 pin socket was corroded by fluid and the blue up button had intermittent operation on the device.There was no procedure nor patient involvement reported.No additional information was provided.

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: h4: the device manufacture date was reported as unknown on the initial report; and has been updated accordingly.

• 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: 12280889
• MDR Text Key: 265168163
• Report Number: 1221934-2021-02394
• 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: 08/05/2021

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: 07/29/2021
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 08/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1