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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK FMS DUO PLUS PUMP & SHAVER COMBO; DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK FMS DUO PLUS PUMP & SHAVER COMBO; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284580
Device Problem Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The defect reported could not be verified but a different defect was identified.This pump is 10 years old and has possibly seen heavy use in the field.The root cause for the reported failure mode cannot be discerned.The following repair activities were conducted: mechanical upgrade performed; unit cleaned; defective material exchanged; 8-hour endurance test carried out; unit calibrated newly; pneumatic circuit checked; functional test performed; hipot test completed; electrical safety test acc.To iec 60601-1 completed; functional test acc.To test procedure completed; safety test checklist enclosed.Further, a review into the depuy mitek complaints system revealed one similar and one dissimilar complaint for this device's serial number.At this point in time, no corrective action is required and no further action is warranted.However, 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.(b)(4).This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
It was reported by the affiliate in (b)(6) that during pre-surgery, it was observed that the pressure was too high on the device.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
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Brand Name
FMS DUO PLUS PUMP & SHAVER COMBO
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key7723157
MDR Text Key115593093
Report Number1221934-2018-52640
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020607
UDI-Public10886705020607
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/26/2014
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 Catalogue Number284580
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/26/2014
Initial Date FDA Received07/26/2018
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 Unknown
Patient Sequence Number1
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