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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
Catalog Number 284004
Device Problems Device Alarm System (1012); Decrease in Pressure (1490); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Not Applicable (3189)
Event Date 01/11/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. (b)(6). Investigation summary: the device was sent to the service center for evaluation. As per the input check report, pinch valve lever is hard to move, irrigation motor intermittently stops running and error code fc002 is being displayed. The device was repaired, pneumatic circuit checked, and functional test performed. Therefore, the root cause for the reported pressure issue can be attributed to user error. 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. At this point, 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. Udi: (b)(4).
 
Event Description
It was reported by the affiliate via phone that during a 'coiffe' procedure, following issues were occurred with their fms vue pump - shaver box. Affiliated stated that the pump got frozen during use, the irrigation roller pumps were not turning and the pressure fell down to zero quickly. This issue was solved by restarting the pump and the case was completed by using the same device. It was stated that a similar issue was occurred earlier in which the pressure dropped from 90 to 44 and that issue has been solved by restarting the pump. The customer has requested a loaner and is considering a replacement. They are also asking and requesting advise regarding the below: ''related to electrode? related to the foot pedal short circuit ? does the pedal need to be changed?". They also wants explanation about the blinking blue led light and the pressure red alert. Additional information received from the affiliate reported the surgeon was not able to see correctly the surgical site due to the incident. The affiliate also reported there was a 5 minute delay with no patient consequence. The affiliate stated the distributor said surgical intervention of some type was planned but further details could not be provided.
 
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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 SàRL
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 
MA  
6103142063
MDR Report Key8847955
MDR Text Key153236157
Report Number1221934-2019-57860
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 foreign,other
Reporter Occupation
Type of Report Initial
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/31/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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