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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL FMS VUE II FLUID MANAGEMENT AND TISSUE DEBRIDEMENT SYSTEM DISTENSION UNIT, FLUID, ARTHROSCOPIC

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MEDOS INTERNATIONAL SàRL FMS VUE II FLUID MANAGEMENT AND TISSUE DEBRIDEMENT SYSTEM DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problem Device Alarm System (1012)
Patient Problem Not Applicable (3189)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Device returned. Investigation summary the device was received and evaluated at the service center. Neither the fault reported by the customer could be verified nor another fault was found with the device during evaluation. The device was cleaned, repaired and tested for functionality. Since the reported condition is not confirmed,the root cause for the reported failure cannot be determined. A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's related to the reported complaint condition were identified. 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. Device history lot a manufacturing record evaluation was performed for the finished device serial number (b)(4), and results obtained as follows: anomalies or discrepancies (non-conformance) : deviation (b)(4) as an response to co (b)(4). Udi: (b)(4). 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.
 
Event Description
It was reported by the affiliate via email that during the surgery the handpiece started to jitter and the fms vue ii pump started to beep to the error message that was displayed on the screen of the pump. The handpiece stopped responding and the foot pedal had to be connected but error and the noise continued. An alternative shaver hp and console had to be used to complete the surgery. No patient consequences were reported, however there was a surgical delayed of about 20 minutes. No additional information was provided. This report is 1 of 1 for (b)(4).
 
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Brand NameFMS VUE II FLUID MANAGEMENT AND TISSUE DEBRIDEMENT SYSTEM
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
FMS
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key9084269
MDR Text Key196398019
Report Number1221934-2019-58389
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeTC
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 08/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284004
Device Catalogue Number284004
Device Lot NumberJ13A70364
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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