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U.S. Department of Health and Human Services

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

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COOPERSURGICAL, INC. FISCHER CONE BIOPSY EXCISOR ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) Back to Search Results
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.
 
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Brand NameFISCHER CONE BIOPSY EXCISOR
Type of DeviceELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Manufacturer (Section D)
COOPERSURGICAL, INC.
95 corporate drive
trumbull CT 06611
MDR Report Key8277283
MDR Text Key134092518
Report Number8277283
Device Sequence Number1
Product Code HGI
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/25/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model Number900-154
Device Lot Number238702
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/02/2019
Event Location Hospital
Date Report to Manufacturer01/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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