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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 Break (1069)
Patient Problem Not Applicable (3189)
Event Date 10/20/2020
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.
 
Event Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2020, it was observed that part of the footswitch device had been broken.A spare device was used to complete the procedure with a 30 minute delay.There were no adverse patient consequences reported.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.H11 additional narrative: 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 complaint device was received at the service center and evaluated.It was reported that footswitch has been broken.Per service reports, this complaint can be confirmed.It was found during evaluation that the reverse function was not functioning, and flow and measurement was out of bounds.Further, cable pins were damaged.The damaged components would have replaced to resolve the issues.However, the device was non-reparable; therefore, the device was not restored to the specifications.User mishandling of the device can be the most probable root causes of the damaged cable pin.With the available information, we cannot determine the root cause of the other identified failures.A manufacturing record evaluation was performed for the finished device serial number ((b)(6)), and no non-conformance was 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
FOOT PEDAL(FMS VUE/NEXTRA)
Type of Device
FOOT-SWITCH, ELECTRICAL
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10854173
MDR Text Key216961945
Report Number1221934-2020-03519
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 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number283573
Device Catalogue Number283573
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/12/2020
Initial Date Manufacturer Received 11/03/2020
Initial Date FDA Received11/17/2020
Supplement Dates Manufacturer Received11/17/2020
01/27/2021
Supplement Dates FDA Received12/16/2020
01/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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