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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 Sparking (2595)
Patient Problem No Code Available (3191)
Event Date 05/24/2017
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. Reference e-complaint: (b)(4). Investigation: 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. Based on the s/n, this unit was manufactured before 2000. Service & repair was not able to duplicate the complaint condition. The unit was evaluated and tested but no failures were detected. Although this unit is over a decade old the check on the unit demonstrated a fully functional unit. There is no definitive root cause for this complaint condition. It is possible there was some end user error or certain conditions were present during the customer's observation(s). Correction and/or corrective action: the unit was evaluated at a charge and returned to the customer. This complaint will be entered into the coopersurgical continuous improvement plan (cip). Reason: no applicable correction available to train to at this time. Complaints will be continuously monitored to determine if there is any new trend for this complaint condition. Was the complaint confirmed? no.
 
Event Description
Reference e-complaint: (b)(4). Review of service and repair log # 85902. "machine was set for cut 50 watt. Patient grounded before machine turned on. Md was not near the foot pedal- pen was down. Vacuum started running a spark hit patient's thigh. ".
 
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 (b)(4).
 
Event Description
Reference (b)(4). Review of service and repair log # 85902. "machine was set for cut 50 watt. Patient grounded before machine turned on. Md was not near the foot pedal- pen was down. Vacuum started running a spark hit patient's thigh. ".
 
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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 Key6663109
MDR Text Key196747680
Report Number1216677-2017-00047
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 Repair
Type of Report Initial,Followup
Report Date 07/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2017
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 Manufacturer05/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/30/2017
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: 06/23/2017 Patient Sequence Number: 1
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