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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG.

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COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG. Back to Search Results
Model Number 909075
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 02/17/2016
Event Type  malfunction  
Manufacturer Narrative
Report as per request from fda medwatch program "this is to bring to your attention that we are in receipt of several supplement reports submitted by coopersurgical, inc. , please be informed that there is no record of initial report submissions in emdr system. It appears that follow-up #1 could be actual initial report but may have been erroneously submitted as follow-up in error. Kindly verify the supplement reports listed below and resubmit follow-up #1 report as initial report electronically through esg webtrader and advise when complete. ".
 
Event Description
Review of repair order log (b)(4). Per repair authorization form: "coag goes soft after 15 minutes (of) minutes. " reference (b)(4).
 
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Brand NameQUANTUM2000 ELECTROSURG.
Type of DeviceQUANTUM2000 ELECTROSURG.
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer Contact
nana banafo
75 coporate drive
trumbull, CT 06611
2036015200
MDR Report Key6392511
MDR Text Key226217921
Report Number1216677-2016-00028
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963653
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number909075
Device Catalogue Number909075
Device Lot NumberN/A
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 Received04/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/09/2017 Patient Sequence Number: 1
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