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

Model Number 225023

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

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.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.Udi: (b)(4).

Event Description

It was reported by the sales rep via phone that during an unknown procedure the vapr 3 footswitch was shorting out.Another device was used to complete the procedure.No patient consequences or surgical delay reported.It is unknown if the device is available to be returned for evaluation.

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 iled as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported by the sales rep via phone that during an unknown procedure the vapr 3 footswitch was shorting out.The complaint device was received and evaluated.Visual observations reveal that the cord was defective due to the cables were exposed.In addition, the device presented several marks of wear.Besides, both pedals presented signs of corrosion and the black push button is missing.The functional test was not performed due to the damages in the cord.The complaint can be confirmed.This device is 11 years old and its failure can be attributed to normal field wear.However, this cannot be conclusive determined.A manufacturing record evaluation was performed for the finished device lot number:0904038, 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.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10624246
• MDR Text Key: 210073255
• Report Number: 1221934-2020-02873
• 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
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2020
• 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: 0904038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 11/16/2020
• Patient Sequence Number: 1