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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US FOOT PEDAL(FMS VUE/NEXTRA) FOOT-SWITCH, ELECTRICAL Back to Search Results
Model Number 283573
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/01/2021
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary: the complaint device was received at the service center/supplier and evaluated. It was reported that cable is broken, and shaver is running without any pause. Per service reports, this complaint can be confirmed. During the service evaluation the following defects were identified: two feet are missing, and baseplate screw is missing the cable is damaged, the shaver activates unintended, the blood stop button is stuck, defective connecting cable, push button switch. The defective connecting cable and push button switch were replaced to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts (3210) was identified as the root cause for the device failure during the service evaluation. Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing. 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.
 
Event Description
It was reported by the affiliate in (b)(6) that the cable on the foot pedal device was broken and the shaver was running without any pause. During in-house engineering evaluation, it was determined that the shaver device was activating unintentionally. There was no procedure nor patient involvement reported. No additional information was provided.
 
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Brand NameFOOT PEDAL(FMS VUE/NEXTRA)
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
6013142063
MDR Report Key12167934
MDR Text Key262004798
Report Number1221934-2021-02209
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705017010
UDI-Public10886705017010
Combination Product (y/n)N
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 07/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number283573
Device Catalogue Number283573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2021
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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