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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 Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical is currently investigating the complaint condition. Once, the investigation is complete, a follow up report wil be filed. Reference e-complaint-(b)(4). 10/3/2017 update: investigation. Analysis and findings: a review of the 2 yr complaint history reveals no similar issues. A review of the dhr reveals no anomalies. This unit was manufactured in 2015. Service & repair found the unit's output was operating to specifications. The arcing was not repeated either. The complaint was not confirmed. Upon visual inspection the unit's outer top casing was significantly scratched exposing bare metal. All the rubber feet were also removed. The repair log notes suggest these may have been contributing factors to the arcing claimed on the complaint. Scratches and removal of the rubber feet indicate the unit was modified or handled incorrectly. The root cause is not definitively determined but it is likely the complaint condition was due to end user error. Correction and/or corrective action: the unit was repaired 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
Per repair authorization form: description of problem: unit makes popping sound when using electrodes on tissue. Arching when using electrodes coag not working on occasion. Repair order number: (b)(4). Reference e-complaint-(b)(4).
 
Manufacturer Narrative
Coopersurgical is currently investigating the complaint condition. Once, the investigation is complete, a follow up report wil be filed. Reference e-complaint: (b)(4).
 
Event Description
Per repair authorization form: description of problem: unit makes popping sound when using electrodes on tissue. Arching when using electrodes coag not working on occasion. (b)(4).
 
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Brand NameQUANTUM2000 ELECTROSURG.
Type of DeviceQUANTUM2000 ELECTROSURG.
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate dr
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate dr
trumbull CT 06611
Manufacturer Contact
nana banafo
75 corporate dr
trumbull, CT 06611
2036015200
MDR Report Key6822041
MDR Text Key256921916
Report Number1216677-2017-00058
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
Type of Report Initial,Followup
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2017
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 Manufacturer07/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2015
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: 08/25/2017 Patient Sequence Number: 1
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