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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG.

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COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG. Back to Search Results
Model Number 909075
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigating the reported complaint condition. (b)(4).
 
Event Description
Customer stated "doesn't cut". (b)(4). Quantum2000 electrosurg 909075.
 
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Brand NameQUANTUM2000 ELECTROSURG.
Type of DeviceQUANTUM2000 ELECTROSURG.
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull, ct
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull, ct
Manufacturer Contact
peter niziolek
50 corporate drive
trumbull, ct 
6015200334
MDR Report Key9993260
MDR Text Key194942536
Report Number1216677-2020-00099
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number909075
Device Catalogue Number909075
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 Received04/07/2020
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: 04/23/2020 Patient Sequence Number: 1
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