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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN

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COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN Back to Search Results
Model Number 52969
Device Problem Failure to Cut (2587)
Patient Problem Insufficient Information (4580)
Event Date 05/21/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc. Is currently investigating the reported condition.
 
Event Description
The loop is not cutting. Order: (b)(4). Leep system 1000 esu gen 52969. E-complaint (b)(4).
 
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Brand NameLEEP SYSTEM 1000 ESU GEN
Type of DeviceLEEP SYSTEM 1000 ESU GEN
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 Key11947981
MDR Text Key263932403
Report Number1216677-2021-00123
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 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number52969
Device Catalogue Number52969
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 Received05/24/2021
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: 06/07/2021 Patient Sequence Number: 1
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