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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE WIRELESS FOOTSWITCH; FOOT-SWITCH, ELECTRICAL
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DEPUY MITEK LLC US VAPR VUE WIRELESS FOOTSWITCH; FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 227214
Device Problems Loss of or Failure to Bond (1068); Circuit Failure (1089)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 affiliate in (b)(6) that the coagulation pedal of a vapr vue wireless footswitch was defective.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.There were no reports of any injuries, medical intervention or prolonged hospitalization.The exact date of the event was unknown but was noted to have occurred in 2019.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Manufacturer Narrative
Product complaint # (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.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).
 
Manufacturer Narrative
Product complaint # (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.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.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the "coag" pedal of the device was defective, was confirmed.The footswitch was found to be physically damaged and not repairable.It was returned without repair as per the instructions from the customer.The physical damage to the device is most likely caused by user mishandling of the device.A manufacturing record evaluation was performed for the finished device [lot : 1601168] number, and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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.Udi:(b)(4).
 
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Brand Name
VAPR VUE WIRELESS FOOTSWITCH
Type of Device
FOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key9480479
MDR Text Key209178144
Report Number1221934-2019-59990
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10886705009657
UDI-Public10886705009657
Combination Product (y/n)N
PMA/PMN Number
K100638
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number227214
Device Catalogue Number227214
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Date Manufacturer Received01/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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