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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR LEEP,

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COOPERSURGICAL, INC. LEEP PRECISION GENERATOR LEEP, Back to Search Results
Model Number LP-20-120
Device Problem Output Problem (3005)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2017
Event Type  malfunction  
Manufacturer Narrative
Ref e-complaint (b)(4). Report as per request from fda medwatch program.
 
Event Description
Reference e-complaint- (b)(4). "the leep would not coagulate after cutting. The tone during coag faded out as the power to the electrode also did. They had to use other means to stop the bleeding. Patient is ok. " s&r log # (b)(4).
 
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Brand NameLEEP PRECISION GENERATOR
Type of DeviceLEEP,
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 Key6722136
MDR Text Key238842945
Report Number1216677-2017-00043
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 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLP-20-120
Device Catalogue NumberLP-20-120
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 Received05/25/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/18/2017 Patient Sequence Number: 1
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