• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP PRECISION GENERATOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOPERSURGICAL, INC. LEEP PRECISION GENERATOR Back to Search Results
Model Number LP-20-120
Device Problems No Display/Image (1183); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 07/08/2020
Event Type  malfunction  
Manufacturer Narrative
The complaint condition reported is currently being investigated by coopersurgical, inc.
 
Event Description
Will not power up correctly to operate. Display fades out does not operate. Order: 94559 from account after follow up: when turning on the unit the led was very dim and in a few seconds the led display would be completely off. I would cycle the power and there would be no display visible. After the unit was power off for about 5 minutes and power cycled back on the same thing would happen again with the led being dim and quickly fading out. I did not witness or hear of an issue with the foot pedal. This was noticed before a procedure. Ref : e-complaint-(b)(4). Leep precision generator lp-20-120 e-complaint-(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEEP PRECISION GENERATOR
Type of DeviceLEEP PRECISION
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 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 Key10395820
MDR Text Key209163968
Report Number1216677-2020-00169
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2020
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/12/2020 Patient Sequence Number: 1
-
-