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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN. LEEP 1000,

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COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN. LEEP 1000, Back to Search Results
Model Number 52969
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
Ref. #: (b)(4). 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 cooper surgical, 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 web trader by checking only "initial" box, and advise when complete.
 
Event Description
Review of service and repair log #: 84194. Follow up questionnaire: "intermittent failure to cauterize. " reference complaint: (b)(4).
 
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Brand NameLEEP SYSTEM 1000 ESU GEN.
Type of DeviceLEEP 1000,
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 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key6307153
MDR Text Key222025270
Report Number1216677-2016-00090
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 Other Health Care Professional
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number52969
Device Catalogue Number52969
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 Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2008
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: 02/07/2017 Patient Sequence Number: 1
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