MAUDE Adverse Event Report: COOPERSURGICAL, INC. 909075

Model Number 909075

Device Problem Activation Failure (3270)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2014

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 cooper surgical, 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 report 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

Ref e-complaint (b)(4).Retrospective review - reference repair log number 77090 per repair authorization form: " no coag activation.".

• Brand Name: 909075
• Type of Device: 909075
• 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 Key: 5612576
• MDR Text Key: 230243566
• Report Number: 1216677-2015-00065
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 909075
• Device Catalogue Number: 909075
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2010
• 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