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

MAUDE Adverse Event Report: ARTHROCARE CORP. FLOW CONTROL UNIT SAW, POWERED, AND ACCESSORIES

  • 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
 

ARTHROCARE CORP. FLOW CONTROL UNIT SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 10101
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Manufacturer Narrative
Reference: case-(b)(4).
 
Event Description
It was reported that the flow control unit was not functioning. It would not prime or run fluid at all through the wand, then it started pumping but it was random, like it was out of timing. It was not controlling the flow smoothly. Incident occurred during an adenoidectomy procedure. The circulating nurse had to manually push fluid because a second device was not available. 30 minutes of delay were reported. No other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLOW CONTROL UNIT
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer (Section G)
ARTHROCARE CORP.
7000 w. william cannon
austin TX 78735
Manufacturer Contact
holly topping
7000 west william cannon drive
austin
5123913905
MDR Report Key11343415
MDR Text Key232377497
Report Number3006524618-2021-00218
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 03/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/18/2021 Patient Sequence Number: 1
-
-