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U.S. Department of Health and Human Services

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

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MEDOS INTERNATIONAL SARL FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). Investigation summary: the complaint device was received at the service center and evaluated. It was reported that ¿review / repair¿. Per service reports, no defect was found with the device, therefore this complaint cannot be confirmed. As the reported problem was not confirmed and no defects identified, a root cause for the issue that was experienced by the user cannot be determined. The service history has been reviewed in lieu of the device history record for this device since it was previously serviced. The device was last serviced on 14/feb/2020 and passed all functional testing before being returned to the customer. 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.
 
Event Description
It was reported by the affiliate in (b)(6) that during service evaluation, it was determined that the handpiece device failed the electrical safety test. There was no procedure nor patient involvement reported. No additional information was provided.
 
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Brand NameFMS VUE PUMP-SHAVER BOX
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SARL
chemin blanc 38
le locle CH-24 00
SZ CH-2400
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle CH-24-00
SZ   CH-2400
6013142063
MDR Report Key12868753
MDR Text Key285370077
Report Number1221934-2021-03440
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2021
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 Manufacturer11/15/2021
Date Manufacturer Received11/16/2021
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 Unkown

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