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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 Problem Failure to Cut (2587)
Patient Problem Insufficient Information (4580)
Event Date 01/05/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc. Is currently investigating the condition reported.
 
Event Description
Customer stated "failure to cut in middle of leep procedure". Repair tech stated "verified". Reference prepare order # (b)(4). Ref : (b)(4). Leep precision generator lp-20-120 (b)(4).
 
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Brand NameLEEP PRECISION GENERATOR
Type of DeviceLEEP PRECISION
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
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trumbull, CT 06611
2036015200
MDR Report Key11232677
MDR Text Key234422370
Report Number1216677-2021-00007
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2021
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 Received01/07/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/26/2021 Patient Sequence Number: 1
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