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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. DEMO QUANTUM 2000

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COOPERSURGICAL, INC. DEMO QUANTUM 2000 Back to Search Results
Model Number DM909075
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/24/2019
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc. Is currently investigating the reported condition. Once the investigation is complete, a follow up report will be filed. (b)(4).
 
Event Description
We used the leep machine on our first patient today. It did not go well. It would not cut or coag. The same spot had to be gone over many times. The watts would not stay constant at 50, would drop down to 25. It was not a good patient experience.
 
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Brand NameDEMO QUANTUM 2000
Type of DeviceDEMO QUANTUM 2000
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer Contact
peter niziolek
75 corporate drive
trumbull, CT 06611
MDR Report Key8412045
MDR Text Key138780499
Report Number1216677-2019-00122
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
Type of Report Initial
Report Date 03/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberDM909075
Device Catalogue NumberDM909075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/22/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/12/2019 Patient Sequence Number: 1
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