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

Catalog Number 225023

Device Problem Failure to Power Up (1476)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(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 the affiliate via cst that during surgery the vapr3 generator *ea and the vapr3 footswitch *ea were plugged in, but it didn't work at all.The vapr did not get any electricity, could not burn the soft tissue.No additional information was provided.

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 is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.One possible root cause for the reported problem could be fair wear and tear due to age and use as the lot number of the device indicates it is over three and a half years old.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device (lot number : 1604112), 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.A manufacturing record evaluation was performed for the finished device (lot number : 1604112), 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.

• Type of Device: FOOT-SWITCH, ELECTRICAL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9123984
• MDR Text Key: 205880306
• Report Number: 1221934-2019-58572
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• 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: 1604112
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/19/2019
• Patient Sequence Number: 1