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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 Accessory Incompatible (1004); 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.Udi: (b)(4).
 
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
Product complaint #(b)(4).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.Additional narrative: concomitant medical products: device returned.Investigation summary the device was received at service center and evaluated.As per the service report the system performing to its specification and no failure was found.The complaint cannot be confirmed.Since the reported condition was not confirmed and no defect was found the root cause for the reported failure cannot be determined and manufacturing record evaluation is not required.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.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.
 
Manufacturer Narrative
Product complaint # (b)(4).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.
 
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.Additional information: b5: subsequent follow-up with the reporter, additional information was received.It was reported that there was suction tubing on the vapr tripolar electrode and a separate suction tubing on the smith & nephew shaver during the procedure.The reporter was not sure what caused the failure on the mitek interface cable; however, it was reported that but the blue light was functioning on the interface cable when the shaver was activated that it was almost as if the interface cable wasn't reading the smith & nephew dyonic's shaver, therefore causing poor visibility and suction issues.It was reported that it was when the shaver was activated within the joint when they saw the issues.It was reported that the outflow was working on the pump.It was reported that the shaver had suction.It was reported that the surgeon did not use the lavage from the pump to stop the bleeding.It was reported that there was an outflow from the pump when the shaver was activated.It was reported that the shoulder on the patient just seemed to be more swollen due to fluid within.The current condition of the patient was unknown.
 
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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 Key9152146
MDR Text Key161240764
Report Number1221934-2019-58787
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 company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/03/2019
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 Manufacturer12/23/2019
Date Manufacturer Received12/23/2019
Patient Sequence Number1
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