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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LP-20-120

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COOPERSURGICAL, INC. LP-20-120 Back to Search Results
Model Number LP-20-120
Device Problem Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2018
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical inc. Is currently investigating the reported complaint condition. The actual device involved in the complaint is expected to be returned for evaluation by customer. Once the investigation is completed a follow-up will be filed. (b)(4).
 
Event Description
Pen stopped working during procedure twice. Have had issues with coag and cutting.
 
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Brand NameLP-20-120
Type of DeviceLP-20-120
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer Contact
peter niziolek
75 corporate drive
trumbull, CT 06611
MDR Report Key7968787
MDR Text Key123950309
Report Number1216677-2018-00060
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
Type of Report Initial
Report Date 10/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/16/2018
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
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/07/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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