• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US FMS VUE PUMP DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284002
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly. (b)(4). Investigation summary: performed service and repair functions. Reviewed service history. Attached box label, software upgrade form, and fms vue final testing. The unit was evaluated and no functional fault was found. Performed software upgrade to the latest versions. Replaced springs on pressure arm housing (preventive maintenance) with tip replacement kit. The unit passed all diagnostic tests, functional tests, and is fully operational. A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint. Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed. This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
It was reported by the sales rep that during an unspecified surgical procedure, it was observed that the fms vue pump device had no suction; and that the toggle was not working. There was no delay in the surgical procedure as an identical spare device was used to complete the procedure. There was patient involvement reported. There were no injuries, medical intervention or prolonged hospitalization. The exact date of the event was unknown. All available information has been disclosed. If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key8284744
MDR Text Key134334396
Report Number1221934-2019-56198
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/15/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/23/2017
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/02/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-