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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC

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MEDOS INTERNATIONAL SàRL FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problem Fluid Leak (1250)
Patient Problem Not Applicable (3189)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Udi: (b)(4). The device was received and evaluated at the service center. There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation. It was found that there was fluid ingress inside the pneumatic circle. Also the pressure stability test failed as the device was leaky and the tamper-proof seal was missing. The cpu board and the pinch valve were also found to be defective and there was inadequate flow with the device. Also there was alarm during operation. The defective cpu board and valve were replaced, the software of the device modified, and the internal pneumatic system was repaired. The device was cleaned, tested and found to be fully functional. The fluid ingress into the device is the most probable root cause for the damage to the cpu board. The cpu board would have triggered the alarm in the device. Also the missing tamper-proof seal is an indication that someone not authorized has opened the device. 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.
 
Event Description
It was reported via affiliate in (b)(6) that the fms vue pump device had an unspecified malfunction. During in-house engineering evaluation, it was determined that there was fluid ingress inside the pneumatic circle in the device. This event did not occur during surgery. There was no patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
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Brand NameFMS VUE PUMP-SHAVER BOX
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key9370635
MDR Text Key207615220
Report Number1221934-2019-59759
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K171237
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 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284004
Device Catalogue Number284004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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