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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 Problems Failure to Cut (2587); Reset Problem (3019)
Patient Problem Insufficient Information (4580)
Event Date 07/20/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical , inc. Is currently investigating the reported condition.
 
Event Description
Report submitted by csi service & repair trumbull. End-user - (b)(6) md, stated- we set up the leep machine as we always have done and had the patient's grounding pad placed correctly. When i started the leep procedure, the machine stopped cutting a few seconds activation with the pedal. I started to remove the anterior cervical tissue and was about half way through the specimen when the machine stopped cutting. It continued to make a sound like it was active but was not working. Additionally, the display kept resetting itself and we had to re-configure it about 15 times during the procedure. The cessation of cutting function seemed to correspond to the display resetting itself and suggests a problem internal to the computerized workings of the device. Also, the cessation of cutting function seemed to happen faster and faster as we continued to proceed with the procedure, in other words, the device cut for shorter and shorter intervals of time the longer we tried to reset it and use it. We confirmed that the grounding pad was well attached and all the devices were firmly plugged in. Leep precision intg sys lp-10-120 e-complaint (b)(4).
 
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Brand NameLEEP PRECISION GENERATOR
Type of DeviceLEEP PRECISION GENERATOR
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer Contact
michael marone
50 corporate drive
trumbull, CT 06611
4752651665
MDR Report Key12327775
MDR Text Key268325626
Report Number1216677-2021-00159
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963348
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberLP-20-120
Device Catalogue NumberLP-20-120
Device Lot NumberN/A
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/28/2021
Was Device Evaluated by Manufacturer? Yes
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: 08/16/2021 Patient Sequence Number: 1
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