• 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 SYSTEM 1000 LEEP 1000,

  • 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 SYSTEM 1000 LEEP 1000, Back to Search Results
Model Number 52969
Device Problem Intermittent Energy Output (4025)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
Ref e-complaint- (b)(4). Report as per request from fda medwatch program.
 
Event Description
Review of repair log (b)(4). Description of problem: "seems as there is a short when cauterizing, will work for few seconds then stops. " repair authorization question: was there a patient involved? yes. Reference e-complaint- (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLEEP SYSTEM 1000
Type of DeviceLEEP 1000,
Manufacturer (Section D)
COOPERSURGICAL, INC.
75 corporate drive
trumbull CT 06611
Manufacturer (Section G)
COOPERSURGICAL, INC,
75 corporate drive
trumbull CT 06611
Manufacturer Contact
nana banafo
75 corporate drive
trumbull, CT 06611
2036015200
MDR Report Key6917454
MDR Text Key234713568
Report Number1216677-2016-00085
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952483
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number52969
Device Catalogue Number52969
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 Received11/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2006
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: 10/05/2017 Patient Sequence Number: 1
-
-