MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE GENERATOR; FOOT-SWITCH, ELECTRICAL

Catalog Number 225024

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate initial reporter phone number: (b)(6).Udi:(b)(4).

Event Description

It was reported by the affiliate that during the procedure, there was a coagulation issue.No patient consequences.No further information.Loaner has been required.

Manufacturer Narrative

Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.Investigation summary: the device was received at service center and evaluated.As per the service report,neither the fault reported by the customer could be verified nor another fault was found.Since there was no defect found the root cause for the reported failure cannot be determined.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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).

• Brand Name: VAPR VUE GENERATOR
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8791619
• MDR Text Key: 151135256
• Report Number: 1221934-2019-57666
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705009121
• UDI-Public: 10886705009121
• Combination Product (y/n): N
• PMA/PMN Number: K041135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/21/2019
• Supplement Dates FDA Received: 08/01/2019
• Patient Sequence Number: 1