• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOPERSURGICAL, INC. QUANTUM2000 ELECTROSURG. Back to Search Results
Model Number 909075
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Information (3190)
Event Date 10/06/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical is currently investigating the complaint condition. Once the investigation is complete, a followup report will be filed. Reference e-complaint-(b)(4). Update 1/2/2018: investigation: analysis and findings: a review of the 2 yr complaint history reveals no similar issues. A review of the dhr reveals no anomalies. The complaint was not confirmed. Service & repair did not duplicate the complaint. The failure description was vague but conveyed the unit was not functioning. The unit functioned to specifications with no defects detected. The root cause for this complaint condition is being attributed to end user error. It is possible the hand piece used by the customer may been over used. The hand pieces are disposable accessory units that are to be replaced. Corrective actions. Correction and/or corrective action : the unit was evaluated under warranty. No defects were noted, hence there was not need to repair the unit. This unit was returned and the customer was notified to use new hand pieces. 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
Unable to cauterize during procedure. Reference e-complaint-(b)(4).
 
Manufacturer Narrative
Coopersurgical is currently investigating the complaint condition. Once the investigation is complete, a followup report will be filed. (b)(4).
 
Event Description
Unable to cauterize during procedure. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7025814
MDR Text Key266430168
Report Number1216677-2017-00070
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 01/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2017
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 Manufacturer10/18/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/30/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/15/2016
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: 11/13/2017 Patient Sequence Number: 1
-
-