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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. LEEP PRECISION GENERATOR Back to Search Results
Model Number LP-20-120
Device Problems Leak/Splash (1354); Dent in Material (2526)
Patient Problem Insufficient Information (4580)
Event Date 04/12/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc. Is currently investigating the reported condition.
 
Event Description
Customer stated "eval". Repair tech stated "unit only with dent in top case - failed coag leakage - adjusted r77. Followed up with repair tech ed mak regarding explanation on "failed coag leaking". Leep precision generator lp-20-120. E-complaint- (b)(4).
 
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Brand NameLEEP PRECISION GENERATOR
Type of DeviceLEEP PRECISION GENERATOR
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer Contact
peter niziolek
50 corporate drive
trumbull, CT 06611
MDR Report Key11862360
MDR Text Key262959835
Report Number1216677-2021-00113
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLP-20-120
Device Catalogue NumberLP-20-120
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 Received04/23/2021
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

Patient Treatment Data
Date Received: 05/21/2021 Patient Sequence Number: 1
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