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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284002
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 has been verified and repaired. The following repair activities were performed service and repair functions as per (b)(4). Reviewed service history. Attach box label and fms vue final testing, software upgrade was not needed. Reseated loose screws on door mounting posts to correct issues. The unit passed all diagnostic tests, functional tests, and is fully operational. A review into the depuy synthes mitek complaints system revealed one other 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 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. Dhr review: part number: 284002 ; supplier lot number: e10a20462; qty of lot: (b)(4); release to warehouse date: 9/25/2014; manufacturing date: 3/1/2014; expiration date: n/a; supplier: (b)(4); manufacturing site: (b)(4); any anomalies or discrepancies in the manufacture of the lot: no. This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions. Udi: (b)(4).
 
Event Description
It was reported that an fms vue pump pressure dramatically decreased during a knee scope procedure. The orange outflow kept making loud clicking noise during procedure. There was no reported patient harm or surgical delay.
 
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Brand NameFMS VUE PUMP
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
5089776860
MDR Report Key8281476
MDR Text Key136149063
Report Number1221934-2019-56152
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2014
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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