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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC
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MEDOS INTERNATIONAL SàRL FMS VUE PUMP; DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284002
Device Problems Poor Quality Image (1408); Suction Failure (4039)
Patient Problem Not Applicable (3189)
Event Date 09/06/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (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.Initial reporter phone number: (b)(6).Udi# (b)(4).The serial number is unknown.
 
Event Description
It was reported by the sales rep via cst that during two cases the fms gave great visibility during all other parts of the procedure, but visibility become poor due to bleeding and suction issues during the acromioplasty.The sales rep was using the pump is duo mode with interface cable.The blue light was functioning on the interface cable when the shaver was activated.It¿s almost as if the interface cable wasn't reading the dyonic¿s shaver.A 3 minutes delay was reported.The procedure was completed with the same device.Fluid extravasation of the shoulder joint was also reported.No other information was provided.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Investigation summary: the device was sent to the service center for evaluation.The work order (wo-392931) indicates: system performing to specification.Therefore, this complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device serial number on (b)(6) 2019, and no non-conformances related to the failure were identified.No further information regarding the cause of the defect has been provided to help determine the actual root cause for this failure.At this point in time, no corrective action is required, and no further action is warranted.However, 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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Subsequent follow-up with the customer, additional information was received.It was reported that the product code was fms vue pump with catalog number 284002 and serial number (b)(4).Therefore, udi: (b)(4).
 
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Brand Name
FMS VUE PUMP
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9158669
MDR Text Key168013933
Report Number1221934-2019-58811
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705027934
UDI-Public10886705027934
Combination Product (y/n)N
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup
Report Date 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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