• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US 4590 FMS SOLO IRRIGATION PUMP -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY MITEK LLC US 4590 FMS SOLO IRRIGATION PUMP -NS DISTENSION UNIT, FLUID, ARTHROSCOPIC Back to Search Results
Catalog Number 284590
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
Device was used for treatment, not diagnosis. Udi: (b)(4). Investigation summary: the complaint device was received at the service center and evaluated. The sales rep reported an issue of the device was not maintaining the pressure. Per service manual operational and diagnostic, this complaint cannot be confirmed. However, the door of the device was found to be broken. It was replaced to resolve the issue. After repair, the device was found to be working according to the specifications. As the reported problem was not confirmed, a root cause for the issue that was experienced by the user cannot be determined. Also, with the available information, we cannot determine what cause the door to get broken. A review of lot/batch history for each legacy fms product complaint received by mitek chu is not recommended since legacy manufacturing no longer exists, and it is no longer possible to make process corrections or corrective actions. At this point in time, no corrective action is required, and no further action is warranted. However, depuy synthes 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.
 
Event Description
It was reported by the sales rep via phone that during a shoulder scope the 4590 fms solo irrigation pump was not maintaining the pressure. Another device was used to complete the procedure without patient consequences. There was a five minute delay reported. During in-house engineering evaluation, it was determined that the door of the device was found to be broken. There was patient involvement. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed. If additional information should become available, a supplemental medwatch will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name4590 FMS SOLO IRRIGATION PUMP -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 LLC US
325 paramount drive
raynham MA 02767
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6013142063
MDR Report Key9495463
MDR Text Key205266123
Report Number1221934-2019-60059
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K002040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number284590
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

-
-