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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. LEEP SYSTEM 1000-110V LEEP 1000 Back to Search Results
Model Number L1000
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/29/2016
Event Type  malfunction  
Manufacturer Narrative
Report as per request from fda medwatch program.
Event Description
Review of service and repair logs (b)(4). Per repair authorization form "foot pedal stops working during case" "disconnecting and reconnecting foot pedal causes cautery to start working again" ref : (b)(4).
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Brand NameLEEP SYSTEM 1000-110V
Type of DeviceLEEP 1000
Manufacturer (Section D)
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
75 corporate drive
trumbull CT 06611
Manufacturer Contact
nana banafo
75 corporate drive
trumbull, CT 06611
MDR Report Key6392885
MDR Text Key240015794
Report Number1216677-2016-00077
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
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 09/24/2016
1 Device was Involved in the Event
0 Patients were 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 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 Received05/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse