MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISHER CONE BIOPSY EXCISOR LG; FISHERCONE BIOP EX LG

Model Number 900-152

Device Problems Break (1069); Thermal Decomposition of Device (1071); Melted (1385); Sparking (2595); Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Date 07/09/2015

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 and advise when complete.".

Event Description

Per incoming complaint call received 7/09/2015."wire broke during procedure, charing on the wire connector.Replaced with a new one from the same lot , had the same issue.Doctor used the same setting with different lot had no issues.Wattage setting was set at 45 , does not know which setting was used , blend or coag." per medwatch received 8/25/2015: "event desc: during procedure, fisher cone biopsy excisior was used following the recommended watt setting 45/50.Surgeon noticed that the wire was not attached and plastic had melted top of excisor.She also noted that sparks were visible coming from tip.A second biopsy excisor was opened that contained the same lot number.This second excisor exhibited the same defects and the surgeon decided to complete procedure using a different product.No harm to patient or staff.".

• Brand Name: FISHER CONE BIOPSY EXCISOR LG
• Type of Device: FISHERCONE BIOP EX LG
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• Manufacturer Contact: banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5612830
• MDR Text Key: 230040666
• Report Number: 1216677-2015-00074
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061651
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/29/2015

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 Expiration Date: 02/28/2018
• Device Model Number: 900-152
• Device Catalogue Number: 900-152
• Device Lot Number: 173468
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other