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

Model Number	900-152
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When md first engaged electrode, there was a flash, assumed tissue, removed and saw plastic melted and smoking.No issues with patient - used another with same lot - worked ok and finished case.Fda safety report id # (b)(4).

• Brand Name: FISCHER CONE BIOPSY EXCISOR LARGE,ELECTRODE
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COOPERSURGICAL, INC. ; trumbull CT 06611
• MDR Report Key: 9948196
• Report Number: MW5094096
• Device Sequence Number: 3131462
• Product Code: GEI
• UDI-Device Identifier: 00888937003727
• UDI-Public: (01)00888937003727
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2020
• Device Model Number: 900-152
• Device Lot Number: 232537
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/09/2020
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 66