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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN. LEEP 1000 Back to Search Results
Model Number 52969
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 03/29/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed a follow up report will be filed. (b)(4).
 
Event Description
(b)(4). Burn mark on patient's leg. Customer reported sn (b)(4)- not a valid number. Will be confirmed once received in at service and repair. Sent to s&r under log # (b)(4).
 
Manufacturer Narrative
Coopersurgical inc. Is currently investigation the reported complaint condition. The device involved in the complaint will be returned by the customer and evaluated. Once the investigation is completed, a follow up report will be filed. (b)(4). Update 05/05/2017- investigation: x- inspect returned samples. Analysis and findings: a review of the 2 yr complaint history reveals one similar issue. A review of the dhr is not available but not expected to provide useful information for this complaint. This unit was manufactured april 2005. Service & repair did not confirm the complaint. The unit functioned to specifications. The root cause for this complaint is being attributed to end user error. With no functional defects noted on the device it is possible the patient pad came loose enough to cause the complaint condition. Additionally, it is possible the patient was under during the procedure. Corrective actions: the unit operated to specifications and returned to the customer at a charge. This complaint will be entered into the coopersurgical continuous improvement plan (cip).
 
Event Description
(b)(4). Burn mark on patient's leg. Customer reported sn (b)(4)- not a valid number. Will be confirmed once received in at service and repair. Sent to s&r under log # (b)(4).
 
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Brand NameLEEP SYSTEM 1000 ESU GEN.
Type of DeviceLEEP 1000
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 Key6464910
MDR Text Key72196157
Report Number1216677-2017-00019
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 consumer,health professional
Reporter Occupation
Remedial Action Repair
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 Received04/06/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number52969
Device Catalogue Number52969
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2005
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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