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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 Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 10/18/2016
Event Type  malfunction  
Manufacturer Narrative
Report as per request from fda medwatch program.
 
Event Description
Medwatch mw5066103. "post-op hemorrhage after leep converted to conization due to incorrect settings on leep machine. " ref : (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 Key6392941
MDR Text Key216841582
Report Number1216677-2016-00093
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 12/22/2016
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? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number52969
Device Catalogue Number52969
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 Received12/16/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/27/2005
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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