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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS.

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COOPERSURGICAL, INC. LEEP PRECISION INTG. SYS. Back to Search Results
Model Number LP-10-120
Device Problems Intermittent Continuity (1121); Failure to Cut (2587)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2019
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
"per rep's telephone report- the leep stopped cutting mid procedure. Leep machine encountered short circuit , jumping between blending and coag. It was reported that leep machine encountered intermittent issues in the process of obtaining patient specimen - dr. Was unable to cut through, eventually had to switch to other means. " (b)(4).
 
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Brand NameLEEP PRECISION INTG. SYS.
Type of DeviceLEEP PRECISION INTG. SYS.
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
50 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key8621424
MDR Text Key145627451
Report Number1216677-2019-00084
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 faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
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: 05/17/2019 Patient Sequence Number: 1
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