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

Model Number 225024

Device Problem Circuit Failure (1089)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by affiliate that the vapr vue generator shows an internal failure code and code 400.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.

Manufacturer Narrative

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.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
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> the device was received and evaluated at the service center.The reported complaint that the device doesn't work and displays error code : 400 12 and "internal failure" was unable to be confirmed.It was however found that the front panel was physically damaged and that the membrane panel had a cut on it.The 8 pin socket was found to be corroded by fluid and the tamper-proof seal was found to be damaged.The damaged front panel and the plug for connecting of the handpiece were replaced, device software modified, and the device was cleaned, calibrated newly, tested and found to be fully functional.Since the reported complaint could not be confirmed, a root cause cannot be determined for the same, however, it is possible that the damaged connector and front panel may have caused the device to not function as intended by the customer.The physical damage to the front panel can be attributed to user mishandling of the device and fluid ingress into the device is the root cause for the corrosion of the 8 pin socket.The damaged tamper-proof seal is an indication that someone not authorized has opened the device.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.Device history lot
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> a manufacturing record evaluation was performed for the finished device (serial number : (b)(6)), and no non-conformances were identified.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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: 9862460
• MDR Text Key: 207746900
• Report Number: 1221934-2020-00942
• Device Sequence Number: 1
• Product Code: HRX
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2020

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: 03/13/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 04/07/2020; 04/10/2020
• Supplement Dates FDA Received: 04/07/2020; 04/10/2020
• Patient Sequence Number: 1