MAUDE Adverse Event Report: COOPERSURGICAL, INC. LEEP SYSTEM 1000 ELECTROSURGICAL GENERATOR; LEEP SYSTEM 1000 - 110V

Model Number L1000

Device Problem Connection Problem (2900)

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

Event Date 10/11/2016

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 reports" " and resubmit follow-up #1 report as initial report electronically through esg webtrader by checking only "initial" box in and advise when complete.".

Event Description

Review of service and repair log.Reference repair log no.83909 per repair authorization form: "poor connection with foot pedal and machine.Was there any patient injury: no" e-complaint-(b)(4).

• Brand Name: LEEP SYSTEM 1000 ELECTROSURGICAL GENERATOR
• Type of Device: LEEP SYSTEM 1000 - 110V
• 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 corpaorate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 6926315
• MDR Text Key: 257484759
• Report Number: 1216677-2016-00081
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: L1000
• Device Catalogue Number: L1000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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