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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US FMS VUE PUMP-SHAVER BOX DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284004
Device Problem Increase in Pressure (1491)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 02/05/2021
Event Type  Injury  
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 by the affiliate in (b)(6) that during a knee arthroscopy procedure on (b)(6) 2021, it was observed that the fms vue pump-shaver box device had an intermittent fluid supply and was making a squealing noise when the shaver handpiece was attached. According to the report, the device was being used in solo mode with the shaver and fluid input being used. It was reported that the surgeon had to abort the case as felt that too much fluid was entering the joint. It was reported that there was excess fluid in calf compartment. It was reported that the patient had to come back for the procedure to be completed on (b)(6) 2021. The status of the patient post-surgery was unknown. No additional information was provided.
 
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Brand NameFMS VUE PUMP-SHAVER BOX
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key11349090
MDR Text Key232581437
Report Number1221934-2021-00598
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K171237
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284004
Device Catalogue Number284004
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/19/2021 Patient Sequence Number: 1
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