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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION

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COOPERSURGICAL, INC. LEEP PRECISION Back to Search Results
Model Number LP-10-120
Device Problems Disconnection (1171); Compatibility Problem (2960); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2021
Event Type  malfunction  
Manufacturer Narrative
Coopersurgical, inc. Is investigating the reported conditon.
 
Event Description
Per csi service & repair trumbull. Customer states the leep unit disconnects from the power socket in the cart when they pull out the return pad (grounding) cable. This in turn loses power with the unit. Customer states this has not occurred with previous generations of the device. Based on the information reported to csi service and repair; there is no report that the device while fully connected did not perform as intended , there was no report of intermittent power during use , additionally there was no report of the device ceasing to function on its own during use while connected to the power supply source. There was no report of adverse event, injury, or medical intervention with regards to patient care. Leep precision int sys (b)(4).
 
Manufacturer Narrative
Coopersurgical, inc. Is investigating the reported conditon.
 
Event Description
Per csi service & repair trumbull. Customer states the leep unit disconnects from the power socket in the cart when they pull out the return pad (grounding) cable. This in turn loses power with the unit. Customer states this has not occurred with previous generations of the device. Based on the information reported to csi service and repair; there is no report that the device while fully connected did not perform as intended , there was no report of intermittent power during use , additionally there was no report of the device ceasing to function on its own during use while connected to the power supply source. There was no report of adverse event, injury, or medical intervention with regards to patient care. Leep precision int sys (b)(4).
 
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Brand NameLEEP PRECISION
Type of DeviceLEEP PRECISION
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 Key12824992
MDR Text Key285339264
Report Number1216677-2021-00265
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 03/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberLP-10-120
Device Catalogue NumberLP-10-120
Device Lot NumberN/A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/16/2021 Patient Sequence Number: 1
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