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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR
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COOPERSURGICAL, INC. LEEP PRECISION GENERATOR Back to Search Results
Model Number LP-20-120
Device Problem No Device Output (1435)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2017
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical is currently investigating the reported complaint condition. The device involved in the complaint has been returned by the customer and is being evaluated. Once the investigation is complete aa follow up report will be filed. Ref e-complaint-(b)(4). Update: investigation analysis and findings: a review of the 2 yr complaint history reveals similar issues. A review of the dhr reveals no anomalies. The complaint was confirmed. Service & repair had confirmed r13 was damaged. Once removed a loose screw was found that had inadvertently gotten in between the chassis and the bottom of the board under r13. The screw is not part of the leep precision assembly at csi. However, this screw was confirmed to be part of the board assembly. Specifically, on the corner of the display board. There is no function for this particular screw in this location. While there is no definitive root cause it clear an extra screw was inadvertently left in the packing, or on the board, which was missed in csi assembly. Isolated incident. Corrective actions: correction and/or corrective action: the unit was repaired and returned to the customer. The vendor was made aware of the finding. A request to remove the screw will be made to engineering on the next update on the board. 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? yes.
 
Event Description
Per repair authorization form: "rep saw/tested w/chicken, 'system ready' everything looked correct /heard tone but when went to cut/coag there was no output. Had to get another leep machine to complete the procedure. " ref. E-complaint-(b)(4).
 
Manufacturer Narrative
Coopersurgical is currently investigating the reported complaint condition. The device involved in the complaint has been returned by the customer and is being evaluated. Once the investigation is complete a follow up report will be filed. (b)(4).
 
Event Description
Per repair authorization form: "rep saw/tested w/chicken, 'system ready' everything looked correct /heard tone but when went to cut/coag there was no output. Had to get another leep machine to complete the procedure. " (b)(4).
 
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Brand NameLEEP PRECISION GENERATOR
Type of DeviceLEEP PRECISION GENERATOR
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 Key6508546
MDR Text Key251450103
Report Number1216677-2017-00022
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 health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLP-20-120
Device Catalogue NumberLP-20-120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/29/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/25/2014
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: 04/20/2017 Patient Sequence Number: 1
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