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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS DUO+ PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS
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DEPUY MITEK MITEK FMS DUO+ PUMP/SHAVER COMBO; FMS EQUIPMENT SYSTEMS Back to Search Results
Catalog Number 284580
Device Problem Unknown (for use when the device problem is not known) (2204)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2014
Event Type  malfunction  
Event Description
The sales rep reported that during a shoulder repair that the customer's hand control interface cable started sparking.The sales rep reported that the device was turned off immediately and the pump and interface were replaced with another pump and interface.The sales rep reported that the device was sparking where the power cord plugs into the interface.The surgeon completed the procedure with no patient consequences or delays.The sales rep could not provide a lot number or age but reported that device has seen heavy use.The sales rep is reporting the pump also to the biomed dept.The sales rep was not present.No further information was available.See associated medwatch # 1221934-2014-00112.
 
Manufacturer Narrative
Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to mitek, however mitek would like to file this initial report at this time.When and if additional information is received it will be reflected in a follow-up report.In transit.
 
Manufacturer Narrative
The complaint device has not been returned till date and there is no further information that would help in the investigation.However it was noted that the associated hand control interface was the cause of the reported event.A review into the depuy mitek complaints system revealed no other complaints for this serial number in the past.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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
The sales rep reported that during a shoulder repair that the customer's hand control interface cable started sparking.The sales rep reported that the device was turned off immediately and the pump and interface were replaced with another pump and interface.The sales rep reported that the device was sparking where the power cord plugs into the interface.The surgeon completed the procedure with no patient consequences or delays.The sales rep could not provide a lot number or age but reported that device has seen heavy use.The sales rep is reporting the pump also to the biomed dept.The sales rep was not present.No further information was available.See associated medwatch # 1221934-2014-00112.
 
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Brand Name
MITEK FMS DUO+ PUMP/SHAVER COMBO
Type of Device
FMS EQUIPMENT SYSTEMS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
quality department
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
na
raynham MA 02767
Manufacturer Contact
david primmerman
325 paramount drive
quality department
raynham, MA 02767
8003824682
MDR Report Key3758633
MDR Text Key4414325
Report Number1221934-2014-00138
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284580
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date01/24/2014
Event Location Ambulatory Surgical Center
Date Report to Manufacturer01/24/2014
Date Manufacturer Received01/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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