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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ELECTROSURGICAL GENERATOR LEEP SYSTEM 1000 - 110V

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COOPERSURGICAL, INC. LEEP SYSTEM 1000 ELECTROSURGICAL GENERATOR LEEP SYSTEM 1000 - 110V Back to Search Results
Model Number L1000
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/11/2016
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 reports" " and resubmit follow-up #1 report as initial report electronically through esg webtrader by checking only "initial" box in and advise when complete. ".
 
Event Description
Review of service and repair log. Reference repair log no. 83909 per repair authorization form: "poor connection with foot pedal and machine. Was there any patient injury: no" e-complaint-(b)(4).
 
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Brand NameLEEP SYSTEM 1000 ELECTROSURGICAL GENERATOR
Type of DeviceLEEP SYSTEM 1000 - 110V
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 corpaorate drive
trumbull, CT 06611
2036015200
MDR Report Key6926315
MDR Text Key257484759
Report Number1216677-2016-00081
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 11/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberL1000
Device Catalogue NumberL1000
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2016
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

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