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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. EEP SYSTEM 1000 ESU GEN

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COOPERSURGICAL, INC. EEP SYSTEM 1000 ESU GEN Back to Search Results
Model Number 52969
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)
Event Date 11/17/2017
Event Type  Injury  
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). Investigation: analysis and findings: a review of the 2 yr complaint history reveals no similar issues. This unit was shipped out april 3, 2007 with no record of it being returned for service. The complaint condition cannot be confirmed as no unit is being returned. A root cause for this complaint condition is not available. It is likely end user error contributed in the complaint description. The information on the complaint indicates the patient was under during the procedure. This will prevent a patients 'feedback' should they ever feel discomfort or pain. Also, the burns were located at the pad site. Even if a patient is sedated, the ifu directs the end user to regularly ensure the pad is fully in place throughout the procedure. If the pad is not in place fully, the current concentrates in the remaining area still in contact with the patient. The result can be burns if enough of the pad detaches from the skin. Correction and/or corrective action: no applicable corrective actions available. This device is no longer being manufactured as of 2016. This complaint will be entered into the coopersurgical continuous improvement plan (cip). Complaints will be continuously monitored to determine if there is any new trend for this complaint condition. Was the complaint confirmed? no.
 
Event Description
Leep procedure was done under anesthesia. Patient went home but later felt burning sensation. Patient discovered 2 lesion (2cm and 3 cm long) 2nd degree burn and went to urgent care. 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
Leep procedure was done under anesthesia. Patient went home but later felt burning sensation. Patient discovered 2 lesion ( 2 cm and 3 cm long) 2nd degree burn and went to urgent care. (b)(4).
 
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Brand NameEEP SYSTEM 1000 ESU GEN
Type of DeviceEEP SYSTEM 1000 ESU GEN
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 Key7143198
MDR Text Key256920751
Report Number1216677-2017-00074
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number52969
Device Catalogue Number52969
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2007
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: 12/22/2017 Patient Sequence Number: 1
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