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

MAUDE Adverse Event Report: ARTHREX INC. MAIN PUMP TUBING ARTHROSCOPE

  • 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
 

ARTHREX INC. MAIN PUMP TUBING ARTHROSCOPE Back to Search Results
Catalog Number AR-6410
Device Problems Detachment Of Device Component (1104); Device Displays Incorrect Message (2591); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication. No additional adverse consequences have been reported from this event. This device is used for treatment. The device was received but has not yet been evaluated. The cause of the event could not be determined from the information available and without device evaluation. Device history record review revealed nothing relevant to this event.
 
Event Description
It was reported that the green part of the tubing disengaged and sucked into the channel about 2/3 into the shoulder scope. The nurse reattached it but it would not hold. The surgeon had to change the case to a mini open because the pump would not run correctly unless the nurse held it together during use. The pump displayed a pump failure error message. It was being run at 40 pressure / 100 flow. Patient (b)(6) year old male.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAIN PUMP TUBING
Type of DeviceARTHROSCOPE
Manufacturer (Section D)
ARTHREX INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath, adverse events
1370 creekside boulevard
naples, FL 34108-1945
8009337013
MDR Report Key7439298
MDR Text Key105760830
Report Number1220246-2018-00129
Device Sequence Number1
Product Code HRX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K083707
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberAR-6410
Device Lot Number102489
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/18/2018 Patient Sequence Number: 1
-
-