• 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 4580 FMS DUO+ PUMP/SHAVER COMBO -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 4580 FMS DUO+ PUMP/SHAVER COMBO -NS; DISTENSION UNIT, FLUID, ARTHROSCOPIC  Back to Search Results
Catalog Number 284580
Device Problem Suction Failure (4039)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2015
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: damaged replaced suction safety cover.This device was produced prior to the closure of the fms facility in nice, france and therefore will not have a device history record (dhr) review preformed.Please see signed legacy fms batch review.This report is being filed from the (b)(4) as required under mitek¿s corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
 
Event Description
It was reported by the customer the suction side of the pump does not work.Both pumps rotate and the tubing clamps are open.Both sides have the proper tubing.It was during an unknown procedure and there were no patient consequences reported.The pump will be returned.Additional information received by mitek complaints via phone on 26october 2015: the customer confirmed no delay in the procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
4580 FMS DUO+ PUMP/SHAVER COMBO -NS
Type of Device
DISTENSION UNIT, FLUID, ARTHROSCOPIC 
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
Manufacturer (Section G)
MITEK RAYNHAM MFG
325 paramount drive
raynham MA 02767
Manufacturer Contact
jennifer lawrence
325 paramount drive
raynham, MA 02767
5088808100
MDR Report Key8010130
MDR Text Key125200940
Report Number1221934-2018-50850
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705020607
UDI-Public10886705020607
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954465
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 10/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number284580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2015
Initial Date FDA Received10/26/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-