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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US VAPR VUE WIRELESS FOOTSWITCH
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DEPUY MITEK LLC US VAPR VUE WIRELESS FOOTSWITCH Back to Search Results
Model Number 227214
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2020
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4).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.No additional information was provided.
 
Event Description
It was reported by the sales rep that during a rotator cuff repair procedure on (b)(6) 2020, it was observed that the vapr vue wireless footswitch device wireless pedal experienced sporadic power when in use.Another like device was used to complete the procedure with minimal surgical delay and no patient consequences.No additional information was provided.
 
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.D9, h3, h6: 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.
 
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.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the wireless pedal experienced sporadic power when in use, was confirmed.It was that the foot switch was not pairing with the generator and that the transmitter pcb was defective.This was replaced to address the reported complaint.Also a hardware upgrade was performed and the device was tested and found to be working according to specifications.However, given the information provided, we cannot discern a definitive root cause of the defective pcb.A manufacturing record evaluation was performed for the finished device (serial : (b)(6), lot : 1204123), 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.
 
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Brand Name
VAPR VUE WIRELESS FOOTSWITCH
Type of Device
VAPR VUE WIRELESS FOOTSWITCH
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key11080191
MDR Text Key224436481
Report Number1221934-2020-04016
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 company representative,user f
Type of Report Initial,Followup,Followup
Report Date 12/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
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 Manufacturer12/30/2020
Date Manufacturer Received01/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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