MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR 3 FOOTSWITCH; FOOT-SWITCH, ELECTRICAL

Catalog Number 225023

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional pro-code: gei.Device received.A review of the device history record has been requested.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 the sales rep via phone that during a shoulder arthroscopy procedure the blue coag pedal on the customer's vapr 3 foot pedal is not working.The procedure was completed with another pedal with no patient harm or surgical delay to the case.The device will be returning for evaluation.This report is 1 of 1 for (b)(4).

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.The complaint device was received and evaluated.Visual inspection reveals that the device is worn but in as expected condition.There were no anomalies noted on the housing, cable, connector, mode button or pedals.The device was taken to a lab and connected to a vapr vue generator and tested.The electrode was connected to the generator and the tip was immersed in saline solution and tested.The ablate pedal functioned as intended.However, there was no function when the coag pedal was activated.Therefore, this complaint can be confirmed.The mode button was also tested and functioned correctly.This testing procedure was repeated several times to confirm the continuity of function of the ablate and mode button and they functioned as in tended.The coag did not.Furthermore, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, 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.However, 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.A review of the device history record.Device history lot a manufacturing record evaluation was performed for the finished device 0706000 number, and no non-conformances were identified.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.

• Brand Name: VAPR 3 FOOTSWITCH
• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9071790
• MDR Text Key: 159044323
• Report Number: 1221934-2019-58365
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: 10886705009114
• Combination Product (y/n): N
• PMA/PMN Number: K041135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 225023
• Device Lot Number: 0706000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 10/11/2019
• Patient Sequence Number: 1