MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ESU GEN.

Model Number 52969

Device Problem Output below Specifications (3004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

Report as per request from fda medwatch program."this is to bring to your attention that we are in receipt of several supplement reports submitted by coopersurgical, inc., please be informed that there is no record of initial report submissions in emdr system.It appears that follow-up #1 could be actual initial report but may have been erroneously submitted as follow-up in error.Kindly verify the supplement reports listed below and resubmit follow-up #1 report as initial report electronically through (b)(6) by checking only "initial" box and advise when complete.".

Event Description

Review of repair order log (b)(4).Per repair authorization form: "coag output too low." reference e-complaint (b)(4).

• Brand Name: LEEP SYSTEM 1000 ESU GEN.
• Type of Device: LEEP SYSTEM 1000 ESU GEN.
• 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 coporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6132603
• MDR Text Key: 234122105
• Report Number: 1216677-2016-00024
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952483
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 52969
• Device Catalogue Number: 52969
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other