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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 Problems Increase in Pressure (1491); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
Udi: (b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that during an unknown procedure on (b)(6) 2021, it was observed that the door on the fms vue pump-shaver box device was not operating correctly resulting in incorrect outflow and lack of suction. Another like device was used to complete the procedure without delay. There were no adverse patient consequences 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 (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 Key12219628
MDR Text Key263257236
Report Number1221934-2021-02275
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
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 Manufacturer08/21/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2017
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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