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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG. QUANTUM 2000

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COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG. QUANTUM 2000 Back to Search Results
Model Number 909075
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint was returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. (b)(4).
 
Event Description
(b)(4). Review of service and repair log # (b)(4). "unit sporadically turns on and off during procedures. " followed up with (b)(6) on 04/05/2017; she reported that the event occurred during the setup and during a procedure prior to entering the patient. They would turn on the machine and then it would flicker on and off. Sometimes it would not turn on at all and needed to restart.
 
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint was returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. Reference e-complaint-(b)(4). Update 05/05/2017: investigation: x- inspect returned samples. Analysis and findings: a review of the 2 yr complaint history reveals no similar issues. A review of the dhr is not available but not expected to provide relevant information for this complaint. This unit was manufactured march 2009. Service & repair confirmed the complaint condition. The board was found to be damaged with loose components moving about freely. The root cause for this complaint condition is end user handling error as well as wear and tear. The unit was obviously damaged through some type of impact or impacts. Correction and/or corrective action: the customer requested the return of the unit as is and purchased a new unit. This complaint will be entered into the coopersurgical continuous improvement plan (cip).
 
Event Description
Reference e-complaint-(b)(4). Review of service and repair log # (b)(4). "unit sporadically turns on and off during procedures. " followed up with (b)(6) on (b)(6) 2017; she reported that the event occurred during the setup and during a procedure prior to entering the patient. They would turn on the machine and then it would flicker on and off. Sometimes it would not turn on at all and needed to restart.
 
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Brand NameQUANTUM2000 ELECTROSURG.
Type of DeviceQUANTUM 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
nana banafo
75 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key6460958
MDR Text Key72193412
Report Number1216677-2017-00018
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 consumer,health professional
Reporter Occupation
Remedial Action Replace
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number909075
Device Catalogue Number909075
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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