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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
Catalog Number 284580
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
It was reported by the affiliate in sweden that during service evaluation, it was determined that the fms duo®+pump/shaver unit device failed the electrical safety test. There was no procedure nor patient involvement reported. No additional information was provided.
 
Manufacturer Narrative
Udi: (b)(4). Investigation summary: the device was received at the service center and evaluated. There was no allegation of malfunction against the device from the customer, however, defects were found with the device during service evaluation. This complaint can be confirmed. During the service evaluation the following defects were identified: motor defective, damage front cover. The motor was replaced to resolve the issues. After repair, the device was found to be working according to the specifications. The faulty parts was identified as the root cause for the device failure during the service evaluation. Manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing. 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.
 
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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 Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key12860325
MDR Text Key283592848
Report Number1221934-2021-03412
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K954465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

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