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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC

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DEPUY MITEK LLC US 4580 FMS DUO+ PUMP/SHAVER COMBO -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284580
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (b)(4). Device was used for treatment, not diagnosis. Udi: (b)(4).
 
Event Description
It was reported by the affiliate via email that the 4580 fms duo+ pump/shaver combo ns was connected to dayonics shaver system via the shaver interface cable so the doctor can control it with the foot pedal, but during the procedure the suction roller pump started to rotate very fast, so there was water in the joints. The only thing that fixes the issue is disconnecting the device from the dayonics. No patient consequence and no surgical delay was reported. No additional information was provided.
 
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Brand Name4580 FMS DUO+ PUMP/SHAVER COMBO -NS
Type of DeviceDISTENSION UNIT, FLUID, ARTHROSCOPIC
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key9673422
MDR Text Key207131170
Report Number1221934-2020-00499
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup,Followup,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number284580
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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