MAUDE Adverse Event Report: COOPERSURGICAL, INC. FISCHER CONE BIOPSY EXCISOR; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Model Number 900-154

Device Problems Melted (1385); Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2018

Event Type  malfunction  

Event Description

The fischer cone biopsy excisor was first used with the electrosurgical unit set at 50 watts of cut and 50 watts of coag on a blend one setting.It failed to cut after a quarter turn.A different 100p tip was obtained to finish the procedure.The wrapper on the initial fischer cone biopsy excisor states that it is recommended for a 40-45 watt setting.The blue insulation at the end of the wire electrode appears to have melted, degraded resin.

• Brand Name: FISCHER CONE BIOPSY EXCISOR
• Type of Device: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8277283
• MDR Text Key: 134092518
• Report Number: 8277283
• Device Sequence Number: 1
• Product Code: HGI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2019,12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 900-154
• Device Lot Number: 238702
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA
• Patient Weight: 64