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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 Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
 
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported the affiliate via email during a shoulder scoping procedure fms vue ii pump was not able to maintain pressure.This was noted pre-operatively.A hand pump was readily available and the surgeon used the back up device to complete the procedure.No patient consequence was reported.However, there was a 5 minutes surgical delay.This is report 1 of 1 for (b)(4).
 
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.Investigation summary: the device was received and evaluated at the service center.The reported complaint that the device wasn't able to maintain pressure was confirmed.It was found that there was damage due to moisture inside the device and also the cover was defective.The tamper-proof seal was found to be missing and the device was not able to hold pressure.The irreparable cover was replaced, the device was cleaned, tested and found to be fully functional.The damaged cover is most likely a result of user mishandling.The defective cover would have caused fluid ingress into the device and would have resulted in the complaint reported by the customer.The damaged tamper-proof seal is an indication that someone not authorized has opened the device.A manufacturing record evaluation was performed for the finished device [serial number : (b)(4)], and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.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.Udi: (b)(4).
 
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.Udi(b)(4).
 
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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 Key9284379
MDR Text Key208353935
Report Number1221934-2019-59439
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705027934
UDI-Public(01)10886705027934
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
Report Date 10/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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 Manufacturer11/01/2019
Initial Date Manufacturer Received 10/09/2019
Initial Date FDA Received11/06/2019
Supplement Dates Manufacturer Received12/04/2019
12/15/2019
Supplement Dates FDA Received12/05/2019
12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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