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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHROCARE CORP. FOOT CONTROL ASSEMBLY SAW, POWERED, AND ACCESSORIES

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ARTHROCARE CORP. FOOT CONTROL ASSEMBLY SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 10863
Device Problems Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Reference: (b)(4).
 
Event Description
It was reported that the foot control was not working. It was not being recognizable in shaver and had a bad port. Incident occurred while setting-up to the procedure. A back-up device was available and no delays occurred. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameFOOT CONTROL ASSEMBLY
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 Key11321546
MDR Text Key233099328
Report Number3006524618-2021-00187
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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 03/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number10863
Device Lot Number284198
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2021
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

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