MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR3 FOOTSWITCH *EA; FOOT-SWITCH, ELECTRICAL

Model Number 225023

Device Problems Use of Device Problem (1670); Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Additional pro-code: gei.Occupation: synthes rep.A review of the device history record has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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.

Event Description

It was reported by the sales rep via phone that during a hand procedure the coag pedal on the customer's vapr 3 foot pedal did not work.The procedure was completed with another like device with no patient harm or surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.This report is for one (1) vapr3 footswitch *ea.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

(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.Mfr site: physical manufacturer.(b)(4).Investigation summary: the device was received and evaluated.Visual inspection reveals that the mode switch dome is missing.The cap for the fischer connector is also missing.The paint is chipped off in several spots on the housing and the pedals.The shrink tubing that is over the cable has slid down about 3 inches from where it usually is inside of the housing and has a couple of cuts in it.The device was taken to the lab and tested.It was connected to a vapr vue generator with an electrode attached.The tip of the electrode was placed in a beaker of saline solution.The ablate pedal on the switch was pressed and functioned as intended.The coag pedal was pressed and did not function.This complaint can be confirmed.A probable root cause could be sterilizing the device with out the cap on the fischer connector allowed fluid to seep into the foot switch.A manufacturing record evaluation was performed for the finished device lot number on 7-22-2019, and no non-conformances were identified.No other information was provided to help determine the root cause of this failure.At this point, as this failure was not confirmed, 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.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.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8893529
• MDR Text Key: 156916360
• Report Number: 1221934-2019-57987
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705009114
• UDI-Public: (01)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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 225023
• Device Catalogue Number: 225023
• Device Lot Number: 1805141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Date Manufacturer Received: 09/03/2019
• Patient Sequence Number: 1