MAUDE Adverse Event Report: COOPER SURGICAL, INC FISHER CONE BIOPSY EXCISOR; ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)

Catalog Number	900-151
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was consented for a laparoscopic tubal litigation, removal of an iud and leep of the cervix.During the leep, the tips of the leep electrode came off the electrode into the patient¿s uterus.A hysterectomy was done to locate the tip of the electrode and it was retrieved.Fda safety report id # (b)(4).

• Brand Name: FISHER CONE BIOPSY EXCISOR
• Common Device Name: ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
• Manufacturer (Section D): COOPER SURGICAL, INC; trumbull CT 06611
• MDR Report Key: 9496499
• Report Number: MW5091773
• Device Sequence Number: 13972981
• Product Code: HGI
• UDI-Device Identifier: 20888937003714
• UDI-Public: 20888937003714
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 05/07/2021
• Device Catalogue Number: 900-151
• Device Lot Number: 238680
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 74