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

Model Number 225023

Device Problem Device Remains Activated (1525)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown.To date, the device has not been returned.If the device, or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

This is report 1 of 2 for the same event.It was reported by the sales rep that during an arthroscopic shoulder stabilization procedure, it was observed that two vapr 3 footswitch got activated when stepped, and would never stop.They had to plugged off these devices to stop them.There were no patient consequences, or surgical delay reported.No additional information was reported.

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: investigation summary: according to the information provided, it was reported by the sales rep via phone that during an arthroscopic shoulder stabilization procedure two vapr 3 footswitch got activated when stepped and would never stop.They had to plugged off these devices to stop them.The complaint device was received and evaluated.Visual observations reveal that the device presented several marks of wear.In addition, both pedals presented signs of corrosion and the black push button is missing.To test its functionality, the device was connected to a vapr vue generator and was set to maximum power for ablation and coagulate test and it did work satisfactorily for both modes.The complaint cannot be confirmed.The possible root cause for the reported failure can be attributed to normal wear and tear.For corrosion found can be attributed to fluid ingress into the footswitch and for missing push button could be associated to lack of preventive maintenance.However, this cannot be conclusive determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.

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.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.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10718843
• MDR Text Key: 212521870
• Report Number: 1221934-2020-03172
• 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: company representative,other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/09/2020

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: 225023
• Device Catalogue Number: 225023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 11/02/2020; 11/09/2020; 12/03/2020; 12/15/2020
• Supplement Dates FDA Received: 11/03/2020; 11/10/2020; 12/04/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1