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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS CONNECT (VUE) FOOT-SWITCH, ELECTRICAL

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DEPUY MITEK LLC US FMS CONNECT (VUE) FOOT-SWITCH, ELECTRICAL Back to Search Results
Catalog Number 282114
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem Not Applicable (3189)
Event Date 04/30/2019
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. Investigation summary: the device was received and evaluated. The device was used in two different complaints for different procedures. Upon visual inspection no anomalies were found. The reported condition accessory device not recognized cannot be confirmed. However,the device was connected to a vapr vue generator. The blue led light indicated the device is receiving power. The led light also blinked when the shaver was activated. Upon operation of the shaver, the pinch valve did not activate. Since the reported condition was not confirmed the root cause for the reported failure cannot be determined. A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified. At this point, 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. 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. Udi: (b)(4).
 
Event Description
The distributor reports that the device didn't work.
 
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Brand NameFMS CONNECT (VUE)
Type of DeviceFOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8851135
MDR Text Key155208395
Report Number1221934-2019-57863
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number282114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/31/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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