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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
Model Number 284004
Device Problem Decrease in Pressure (1490)
Patient Problems Edema (1820); No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
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.Additional information: (b)(4).Udi: (b)(4).
 
Event Description
It was reported by the affiliate via phone that the fms vue pump - shaver box is defective.The affiliate reported the surgeon had to do a manual hyper-pressure in order to complete the procedure.It was reported the pressure only turned to 40-50.The affiliate stated the surgeon was unhappy and the patient's shoulder was very swollen.The surgeon immediately stopped working with the pump and the rest of the intervention went well.It was reported that procedure was prolonged over 30 minutes due to issues with the pump.No additional hospitalization / medication required to treat the swollen shoulder.The affiliate reported this pump was the same machine as for the 1st problem occurred on (b)(4) 2019.
 
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.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.H10 additional narrative: investigation summary = the complaint device was received at the service center and evaluated.It was reported that the fms vue pump - shaver box is defective, the unit needed to constantly do a manual hyperpressure, otherwise it only turned to 40 or 50.Per service manual operational and diagnostic, the reported failure was not confirmed.During the input inspection of the device, it was noticed that the indicated pressure fluctuated strongly.The pump indicate pressure drops below the set value when flow+ or shaver is activated; because of that, the equipment was sent to supplier for further investigation.Upon received the device back, the manufacturer stated that no failure could be found, the unit passed all the required tests.Customer complaint cannot be confirmed.The unit passed all functional tests and is fully operational.The possible root cause for issue experienced with customer could be related with the installation/configuration/consumable (tubing) and/or the use during the surgery at the hospital.Please see email attached as evidence.However; this cannot conclusively affirm.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 10-07-2019 and passed all functional testing before being returned to the customer.At this time, no corrective action is required, and no further action is warranted, as the device was repaired and is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.Device history lot = 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 10-07-2019 and passed all functional testing before being returned to the customer.
 
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.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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the initial pressure setting was 110mm hg.It was reported that the surgeon used elevation as it was not required.It was reported that the surgeon used solo for knee and duo for shoulder.It was reported that the surgeon used shaver during procedure.It was reported that the procedure was shortened as the shoulder was too swollen.
 
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.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.H10 additional narrative: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
FMS VUE PUMP-SHAVER BOX
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key9569296
MDR Text Key188654333
Report Number1221934-2020-00105
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,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number284004
Device Catalogue Number284004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/08/2020
Date Manufacturer Received04/23/2020
Patient Sequence Number1
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