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U.S. Department of Health and Human Services

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

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DEPUY MITEK LLC US FMS DUO+PUMP/SHAVER UNIT DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Model Number 284580
Device Problems Infusion or Flow Problem (2964); Output Problem (3005); Suction Failure (4039)
Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (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. Udi: (b)(4).
 
Event Description
It was reported via complaint submission tool that during a stabilisation and cuff repair a fms duo+ pump/shaver combo stopped suction. The foot pedal stopped working also with the interface cable. This occurred a couple of times. Also two expressew iii autocapture + retention plate/loading tool-single pack did not load. Pump was started again and another retention plate was opened to complete procedure with a surgical delay of 2 minutes. No patient consequences reported.
 
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Brand NameFMS DUO+PUMP/SHAVER UNIT
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 Key10847944
MDR Text Key217338538
Report Number1221934-2020-03501
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2020
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 Manufacturer12/07/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2021
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
Removal/Correction NumberN/A

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